Product samples tested positive for lead.  Finished curry products tested and ground turmeric ingredient used to manufacture the curry seasoning also tested positive for lead.
Mild Curry Powder. Packaged under the names: Blue Mountain Country Jamaican Curry Powder, Jamaican Choice Jamaican Curry Powder, Ocho Rios Jamaica Nice Curry Powder Seasoning, Ocho Rios Jamaican Style Curry Powder, Oriental Brand Grade A Jamaican Curry Powder, Grace Jamaican Style Mild Curry Powder, Grace Caribbean Tradition Curry Powder. Sold as 2 oz, 4 oz, 6 oz, 8 oz,  22 oz, and 5 lb.
Hot/Spicy Jerk Curry Powder. Packaged under the names: Blue Mountain Country Hot Jamaican Jerk Curry Seasoning & Ocho Rios Spicy Jerk Curry Seasoning. Sold as 2 oz, 4 oz, 6 oz, 8 oz,  22 oz, and 5 lb.
Mild Jerk Curry Powder. Packaged under name Ocho Rios Mild Jerk Curry Seasoning. Sold as 2 oz, 4 oz, 6 oz, 8 oz, 22 oz, and 5 lb.
1) Ground Tumeric item #73535 Net Wt 50 lbs  Distributed by Gel Spice Co., Inc 48 Hook Road,   Bayonne, NJ 07002    2) Spice Supreme Ground Turmeric Net Wt 2 oz. (56 g)  Packed in the USA by Gel Spice Co., Inc. Bayonne, NJ 07002  UPC 076114364628    3)Clear Value Ground Turmeric  Net Wt. .75 oz (21 g)   Distributed by TopCo Associates LLC Elk Grove Village, IL 60007, UPC 036800354920      4) Market Pantry Ground Turmeric, Net Wt. 0.95 oz.  Distributed by Target Corporation Minneapolis, MN 55403 Product of India UPC 085239211038                 5)  Spice Select Ground Turmeric, Net Wt 8 oz.(227g), Distributed By: GelSpice, Co., Inc., Bayonne, NJ 07002, UPC 076114007730                       6) Lieber's Turmeric, Net Wt. 2 oz (56g), Dist by Lieber's Chocolate & Food Products Co, Maspeth, New York 11378, UPC 04342700626          7) Gel brand Ground Turmeric, Net Wt. 15 oz., (425g) Plastic Bottle, Packed by Gel Spice Co., Inc., Bayonne, NJ 07002, UPC 076114800867     8) b'gan seasonings Ground Turmeric NET WT. 16 oz 1 LB (454 g) Dist. by S. Bertram. Inc, Linden, NJ 07036 UPC     9) Freshly Ground Turmeric Net Weight 2.8oz (79g) Orient Provision & Trading Co. LTD UPC 6281063884002    10) Spice Supreme Ground Turmeric Net Wt 2 oz. (56 g) Gel Spice Co., Inc. Bayonne, NJ 07002 UPC 07611436462    11) Fresh Finds Ground Turmeric Net Wt. 3.75 oz (106g) Distributed by: Big Lots Stores, Inc. PO Box 28523 Columbus OH 43228-0523 UPC 08102601230
34,712  pounds total for all recalled products
Ground Turmeric may contain excess levels of lead.
Ground Turmeric packaged as follows:  a) FOOD LOCKER(R) , 16 oz, PHENIX FOOD SERVICE, PHENIX CITY, AL  36867  b) Ground Turmeric, Net Wt. 4 oz.,
The firm received a notice from their supplier that a sample of ground turmeric was tested and found to have elevated levels of lead.
Frozen Raw Bay Scallops, packaged in a clear 5 lbs. bag, (six bags per case or total 30 lbs. case), food service product item, product of Philippines. There are three different sizes:    size 120/150 (count per pound)  size 150/200 (count per pound)  size 200/300 (count per pound)
Frozen Raw Bay scallops are recalled due to a potential contamination with hepatitis A virus.
Warehouse Receipt Lot numbers: 5885, 5886, and 5887.    Manufacturer production (Processed/Packed) dates observed on master carton: November 23, 2015 orNovember 24, 2015.    Manufacturer production code observed on master carton: DOSM-M1.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Cedar Crest Pirate's Bounty Ice Cream  1.5 quarts (1419 mL)
The cookie dough used in select ice creams may be contaminated with Listeria monocytogenes.
Cedar Crest Monster Cookie Dough Ice Cream in 3 Gallon container.
Cedar Crest Chocolate Chip Cookie Dough Ice Cream packaged in the following sizes:  Pint, 1.5 Quarts, and 3 Gallon
PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany, MADE IN FRANCE; packaged in A) Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51) in a) bundles of 10 unit cartons (NDC 0008-0923-55) and b) 25 x 40 mg Vials per carton (NDC 0008-0923-60); B) NOVAPLUS, 1 vial per carton (NDC 00008-0941-01) in 25 x 40 mg Vials per carton (NDC 0008-0941-03); and C) PREMIERPro Rx, 1 vial per carton (NDC 0008-4001-01) in a) bundles of 10 unit cartons (NDC 0008-4001-10) and b) 25 x 40 mg Vials per carton (NDC 0008-4001-25).
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Producers 210/1036 Range Mix #2 For Cattle on Pasture Manufactured by Producers Cooperative Association Bryan, Texas 77806 Net Weight 50 lbs. (22.68 kg) or Bulk
Producers 460/1123 Cattle Pellet 1.0 Medicated Manufactured by Producers Cooperative Association Bryan, Texas 77806 Net Weight 50 lbs. (22.68 kg) or Bulk
Producers 478 Show Goat Medicated For Growing Goats (For Ruminants Only) Manufactured by Producers Cooperative Association Bryan, Texas 77806 Net Weight 50 lbs. (22.68 kg) or Bulk
Producers 472/1105 Cattle Pellet 1.5 Medicated Manufactured by Producers Cooperative Association Bryan, Texas 77806 Net Weight 50 lbs. (22.68 kg) or Bulk
The Sweet Dessert Corp., Tres Leches Chocolate (Three Milk Cake with chocolate), Peso Neto (Net Weight) 3oz and 4 oz., Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
Undeclared food color: Yellow #5 and Yellow #5 lake, and Yellow #6 and Yellow #6 lake
The Sweet Dessert Corp., Cheesecake Cherry, Peso Neto (Net Weight) 3oz and 4 oz., Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
The Sweet Dessert Corp., Tres Leches (Three Milk Cake), Peso Neto (Net Weight) 3oz and 4 oz., and 4oz (large label) Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
Undeclared food color: Yellow #5, Yellow #5 lake, and Yellow #6 and Yellow #6 lake
The Sweet Dessert Corp., Cheesecake Fresa (Strawberry), Peso Neto (Net Weight) 3 oz and 4 oz (small labels)3 and 4oz (large label), Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
Undeclared food color: Red #40: (3oz and 4oz, small labels)  Undeclared Milk: 4oz (large label) and 3oz and 4oz (small labels)
Undeclared Milk  Undeclared food color:  Yellow #5, and Yellow #6.
The Sweet Dessert Corp., Cheesecake Guayaba (Guava), Peso Neto (Net Weight) 3oz and 4oz and 4oz (large label)., Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
Undeclared Milk: Milk (small label 3oz and 4oz and large label 4oz)   Undeclared food color: Red #40 (small label 3oz and 4oz)
The Sweet Dessert Corp., Cheesecake Parcha (Passion Fruit), Peso Neto (Net Weight) 3oz and 4 oz., Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
Undeclared Milk  Undeclared food color: Red #40, Yellow #5, and Yellow #6  Undeclared Aspartame
USA ( nationwide ) Distribution to the states of : WA, OR, CA, OH, IL, CT, IA, KY, AL, LA, HI, PA, NJ, DE, MN, DC, NY, MI, SC, MD, TN, OK, WI, UT, ID, NV, TX, AL, IN, WV, KS, MO, CO, MT, MS, NC, GA, NH,UT, FL, AZ and ND.
Toshiba Kalare DREX-KL80 X-ray generator
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
Toshiba Ultimax DREX-ULT80 X-ray generator
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key presses the pump will display the incorrect message. The message indicates that a Patient Controlled Analgesia (PCA) dose is unavailable because the pump is running. It should indicate that the PCA dose is not available because the pump is stopped. The function of the pump is unchanged and no patient injury can occur since no drug is being delivered.
VASOVIEW HEMOPRO VH-3500  ENDOSCOPIC VESSEL HARVESTING SYSTEM    Product Usage:  The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power.
U.S. distribution to the following; nationwide.    Foreign distribution to the following; Netherlands, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.
The affected analyzers are serial numbers 393-090R0027N001 to present.
ABL90 Flex  Model #: 393-090     Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.
distributed in AZ, CA, CO, IA, IL, MD, MI, NC, NJ, NV, NY, OR, and WA.
The allergens such as soy, milk, almond, coconut, hazelnut, and/or wheat are declared on an insert label inside of the assorted boxes, and not declared on the exterior of the boxes.
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Worldwide Distribution - US Nationwide and the countries of Germany, Belgium, The Netherlands  United Kingdom and China.
The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller.  That could compromise the integrity and result in damage to the Controller Cap.
Blood products, in which donor history warranted deferral or follow up questions were not asked, were distributed.
Blood and Blood Products for Reprocessing
MA, NJ, NY, IL, MD, FL, MO, TX, IN, GA, DE, CO, VA, PA, CT, OR, VA, AZ,  Through asianl herb stores, acupuncture clinics and asian supermarkets.
Xanthium & Siler Combo (Bi Yan Pian) DIETARY SUPPLEMENT, Net cont: 100 tablets (300mg each), Net Wt. 1.06oz (30g)
Presence of Ephedrae Herba (ma huang), a FDA Banned  Ephedra Alkaloid
American National Red Cross (The) - North Central Region
Blood products, in which quality control and distribution of products did not meet specifications, were distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Thornton's Hollow Milk Chocolate Jolly Santa, 200g, Barcode: 5016346234721
LBB Imports is recalling Thornton's Hollow Milk Chocolate Jolly Santa because it may contain a piece of plastic which could present a potential risk to consumers.
Blood products, collected from a donor whose deferral was missing or incorrectly identified on the deferral list, were distributed.
Worldwide Distribution - US nationwide and internationally in the following countries: BOLIVIA, CANADA, CHINA, ECUADOR, FRANCE, IRELAND, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PANAMA, PERU, POLAND, UNITED KINGDOM.
Arkon Anesthesia Delivery System, Model 99999.    Product  Usage:  Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to use Emergency O2 and manually ventilate the patient, providing gas and agent. However, the anesthesiologist will not have access to mechanical ventilation or ventilator monitoring.
325 devices sold to 35 US consignees and 76 devices sold to 14 international consignees
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56
US: CA, ILM NC, GA, NE, MA, CO, CT, MO, TN, LA, MD, MN, FL, SC,M OK, MI, PA, TX, WA, WI.
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.
MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C  The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets
CareFusion is recalling the MaxGuard Extension Set  due to reports of leaks occurring with the 0.2 micron filter.
Goulibeur- Cube tin box Life in Paris, containing mini heart-shaped pure butter shortbreads  Net weight 4.23 oz
This recall has been initiated due to missing information about the presence of the milk allergen in the list of ingredients. It is written that the products contain butter, but the food source for this ingredient (milk) is not indicated.
Batch number : 16490  Best-by date : 08/15/2017
Goulibeur - Large pure butter shortbread with flaked almonds, in neutral gift wrapping  Net weight 13.5 oz
Batch number : 16483  Best-by date : 08/15/2017
Goulibeur  Cube tin box with pictures of France, containing small pure butter shortbreads  Net weight 4.23 oz
Goulibeur - Pack of 15 pure butter shortbreads in 3 freshness packs  Net weight 9.87 oz
Goulibeur - Large French walnut shortbread, in paper carton box  Net weight 9.87 oz
Batch number : 16474  Best-by date : 08/15/2017
Batch number : 16493  Best-by date : 08/15/2017
Merge Hemo software.      Product Usage:  Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
361 sites potentially have the affected versions
In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.
Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of: Mexico, AUSTRALIA, UNITED ARAB EMIRATES (UAE), Indonesia, Singapore, Taiwan, Thailand, COLOMBIA, CHILE, Vietnam, India, China, Malaysia, BELGIUM, Japan, CANADA
Terumo Advanced Perfusion System 1-Level Sensor II Pads,     Product Usage:  Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling  because the product expiration date is displayed in a format that may not be recognizable to all users.
Level Sensor II Pads, Catalog No. 195240, UDI No: 10886799001704, Lot Numers Ranging from 782300 through 817488, Manufactured from 20-Nov2015 to 25-Nov-2016; Distributed from 23-Nov-2015 through 15-Dec-2016.
Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads    Product Usage:  Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
Level Sensor II Gel Pads, Catalog No. 217390, UDI No: 00886799000519, Lot Numers Ranging from 782300 through 817488, Manufactured from 19-Nov-2015 to 25-Nov-2016; Distributed from 23-Nov-2015 through 15-Dec-2016.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Mirtazapine Tablets, USP, 45 mg.  Rx only, 100 Tablets (10 X 10).  Manufactured by:  Mylan Pharmaceuticals Inc, Morgantown, WV
58 UD100 Unit Does Blister Cards of 10 (10 cards of 10 tablets each)
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
NSM, Extra Fine Granulated Sugar, Net Wt. 50 lbs. (22.7 kg), in a poly liner.
84/2200 lb. supersacks and 681/50 lb. bags
Foreign material (rubber) detected in product.
RETINOIC ACID all strengths including 0.025%, 0.05% and 0.1% CREAM, RETINOIC ACID 0.025%/CLINDAMYCIN 1.2% GEL,  RETINOIC ACID 0.025%/ HYALURONIC ACID CREAM, RETINOIC ACID 0.05%/HYALURONIC ACID   CREAM, RETINOIC ACID 0.1% IN CERAVE CREAM, RETINOIC ACID POWDER 1 GRAM, RETINOIC ACID/HYALURONIC ACID 0.1%/0.1% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin otc 2%, Azeliac acid 2%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
GENERIC VI PEEL (Sal Acid 2%, TCA 7% Phenol 7%, Retinoic Acid 0.4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
REVERSE DML LOTION (Ketoconazole 2%, Metronidazole 2%, sulfacetamide sodium 10%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
ROSACEA CREAM ( Metronidazole 1%, Niacinamide 4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 8%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
CLEAR 2  (Benzoyl Peroxide 2.5%, Clindamycin 1.2% ), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
LP CREAM (Lidocaine 15%/Prilocaine 5%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
SULFACETAMIDE 10%/HYDROCORTISONE 1% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
VI PEEL (Sal Acid 2%, TCA 17%, Phenol 7%, Retinoic Acid 0.4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
MELATONIN 1.5MG SPRAY, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
KETOCONAZOLE 2%/HYDROCORTISONE 1.5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676.
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, Rx only, Synergy Rx, 4901 Morena Blvd #504-A San Diego, CA 92117 (855) 792-6676
DUO Cream (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocortisone 0.1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
VITAMIN K OXIDE 5%, HQ 4%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
SULFUR 5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
RETINOIC ACID SOLUTION in all strengths including 0.3%, 0.4%, 0.5%, 1%, RETINOIC ACID SOLUTION LIQUID, 0.4%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
ENHANCED RETIN ANTI-WRINKLE CREAM, ENHANCED RETIN ANTI-WRINKLE CREAM 0.1%, ENHANCED RETIN 0.025% and 0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
QUAD BLEACHING CREAM (retinoic acid 0.05%, hydroquinone 6%, kojic aid 3%, hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
UREA 40% Cream, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
ACNE SOLUTION (Salicylic acid 2%, Hydrocortisone 2%, Niacinamide 4%, Azelaic acid 2%, Clindamycin 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
HYDROCORTISONE 2.5% WITH ALOE VERA CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
TRETINOIN CREAM in all strengths including: 0.1%, 0.05%,  TRETINOIN GEL in all strengths including 0.1% and  0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
TRETINOIN 0.02% IN OIL FREE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
KOJIC ACID 8%/AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
PURIFIED WATER, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
TCA PEEL SOLUTION in all strengths including: 5%, 10%, 15%, 18%, and 20%, TCA 10%/LACTIC ACID 12%, TCA 6%/ LACTIC ACID12%, TCA 7%/SALICYLIC ACID 2% SOLUTION,  Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM,   Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
CUSTOM LIGHTENING/BRIGHTENING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
BETAMETHASONE 0.25%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
INTIMATE BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
GENTLE BLEACHING CREAM (Retinoic Acid 0.025, Kojic Acid 3%,Hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% OINTMENT, CLOBETASOL 0.05%/ SODIUM, SULFACETAMIDE 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
JESSNERS PEEL (salicylic Acid 14% rescorcinol 14%, Lactic acid 14%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
BRIGHTENING CREAM (Retinoic acid 0.1%, Hydroquinone 4%, kojic acid 3%, hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
FIRM AND FADE (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
HCG and HCG with resveratrol Human Chorionic Gonadotropin in different strengths: HCG 300 UNITS/RESVERATROL 50MG S.L. Tablet, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
ENHANCED RETIN ANTI-WRINKLE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
TRI-BLEACHING CREAM HQ (retinoic Acid 0.05%, Hydroquinone 6%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
BENZOYL PEROXIDE 5% CLINDAMYCIN 1.2%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%,   LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% CREAM,   LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% OINTMENT  LIDOCAINE 23%/ TETRACAINE 7% CREAM,  LIDOCAINE 23%/TETRACAINE 7% OINTMENT, LIDOCAINE 23%/TETRACAINE 7%/PRILOCAONE 2.5%, LIDOCAINE 24%/PRILOCAINE 26% OINTMENT, LIDOCAINE 30%/TETRACAINE 4% /PRILOCAINE 2%, LIDOCAINE 30%/PHENYLEPHRINE 0.25%, LIDOCAINE 30%/ TETRACAINE 10%, MELYLEPHRINE 4%, LIDOCAINE 30%/TETRACAINE 4%/PRILOCAINE, LIDOCAINE 7%/TETRACAINE 7% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
MALEK'S MAGIC (retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
HYDROQUINONE CREAM  in all strengths including 4%, 5%,6%, 7%, 8%, HYDROQUINONE 5%/KOJIC ACID 3% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
SUPREME BLEACHING CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin OTC 2%, Azeliac acid OTC 2%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
HYDROQUINONE 28% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
CLARIFYING CREAM (Retinoic acid 0.025%, Salicylic Acid 1%, Green tea powder, Ascorbic acid 2%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
TRI-BLEACHING CREAM (Retinoic Acid 0.1%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
QUAD PEEL (Sal Acid 2%, TCA 7%, Phenol 7%, Retinoic acid 0.4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2,5% GEL, AZELAIC ACID 15% CREAM, AZELAIC ACID 20% IN OI FREE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
CANTHARADIN 0.7% SOLUTION  and  CANTHARIDAN / PODOPHYLLUM  SOLUTION, CANTHARIDIN/PODOPHYLLUM RESIN MIXTURE, Rx only,  Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
CLINDAMYCIN 1%, AZELAIC ACID 10% CREAM, CLINDAMYCIN 1.2%/ TRETINOIN 0.05% GEL, CLINDAMYCIN 1.2%/ TRETINOIN 0.1% GEL    CLINDAMYCIN 2.5%, BENZOYL PEROXIDE 5%,  Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
BICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
ULTRA LITE CREAM (Hydroquinone 8%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
GLYCOLIC ACID 15% LOTION, GLYCOLIC ACID 20% GEL, GLYCOLIC ACID 6% LOTION, GLYCOLIC ACID 5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
RETIN-A 0.05% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
DICLOFENAC 3% and 5% LIP BALM and DICLOFENAC 5% SPF 30 LIP BALM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
HCG in all strength including: 2,400, 9600,12,000 UNIT POWDER VIAL DROPS, HCG 11,000/B-12 UNITS SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
LACTIC ACID SOLUTION in all strengths including 20%, 30%, and 60%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
ERYTHROMYCIN 2% IN CERAVE CREAM, ERYTHROMYCIN 3% / RETINOIC ACID 0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
FLUORORACIL 0.05% CREAM, FLUORORACIL 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM,  Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
FLUOCINONIDE 0.05% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
HYDROQUINONE CREAM in all strengths including: 4%, 5%, 6%, 7%, 8%,10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
HYDROQUINONE SOLUTION  in all strengths including 4%, 28%,  Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
GLYCOLIC ACID SOLUTION, all strengths including 10%, 20%, 30%, 50%, and 60%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Human Chorionic Gonadotropin (HCG)  5,000 units/vial and 11,000 units/vial, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
GENTLE SUPREME BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
CALMING CREAM (Hydrocortisone 2.5%, Aloe vera powder), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
TRICHLOROACETIC ACID SOLUTION in all strengths including: 10%, 12%, 15 %,  20%, 35%, 70%, and 85%, TRICHLOROCETIC ACID 10%/ LACTIC ACID 12%, TRICHLOROCETIC ACID 6%/LACTIC ACID 12%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
BLEACHING CREAM 0.1% CREAM, BLEACHING CREAM HQ4%, BLEACHING CREAM-NO HQ, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
MALEK'S MAGIC PLUS (retinoic acid 0.1%, hydroquinone 6%, kojic acid 3%, hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
MODIFIED JESSNER PEEL (Sal Acid 14%, Lactic Acid 14%, glycolic 14%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
SALICYLIC ACID SOLUTION in all strengths including  20%, 25%, 30%, and 40%,  SALICYCLIC  ACID 20%. 2.5%5-FU, SALICYCLIC ACID 20%,  5-FU 2.5% CREAM,  SALICYCLIC ACID 20%/5-FU 2.5% MEDICATION STICK,  Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
RTI Biologics BioSet IC RT Paste 2 cc    Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
Incorrect instructions for use (IFU) included.
CHOICE FARMS Traditional Gourmet Portabella Mushroom, 8 oz. INDIVIDUAL SHRINK-WRAPPED TRAYS
Possible contamination with Listeria monocytogenes.
Choice Farms Pizza Style Portabella Mushrooms 8 oz. INDIVIDUAL SHRINK-WRAPPED TRAYS
CHOICE FARMS Stuffed Mushrooms, 7 oz. INDIVIDUAL SHRINK-WRAPPED TRAYS
Worldwide distribution.  US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore,   SPAIN, SWITZERLAND, UAE, and UK
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU)  REF#  e2401-51
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU)  REF#  2401-51
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU)  REF#  e2401-53
LeMaitre Vascular  Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU)  REF# 2401-53
Lot Number/Exp. Date:  RST2413    2019-01
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU)  REF#  2401-50
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU)  REF#  e2401-52
LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU)  REF# e2400-50
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU)  REF#  2401-52
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU)  REF# e2400-51
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU)  REF # e2400-53
LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU)  REF # e2400-52
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU)  REF#  e2401-50
Worldwide distribution.  US nationwide,   ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CAYMEN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, FINLAND, FRANCE, GABON, GERMANY, GREAT BRITAIN, GREECE, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN,  SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, & VIETNAM.
882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).
Four issues:   1. Motion controller problem stops scan and no data image produced.   2. Door interlock switch problem disables CT scan.   3. Detector contacts head holder when performing Patient Unload.   4. JETStream freezes during gated planar scan
882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).
882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).
Worldwide Distribution - US Nationwide in the states of MO and country of Switzerland.
L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France.    Product Usage:  The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Firm received a complaint of the tip holder breaking during use.
US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
BNX  Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
BNX  Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
Box Mill Farm Pasteurized Apple Cider in 1 gallon containers and Half-Gallon containers
250 (total); 134 cases gallon (4 case) ; 116 cases half-gallon (9/case)
Inadequate pasteurization of apple cider
PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL), Colgate Oral Pharmaceuticals, Inc., New York, NY 10022 --- NDC 0126-0016-61, UPC 3834110622
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Krispy Kreme Chocolate Iced Sprinkle Theme, 6 count boxes (UPC 0 72470 00029 3), Single served (UPC 004-02300-001).
Product may contain foreign matter, metal pieces.
Krispy Kreme Doughnuts Choc Iced Custard Filled, 2 count boxes (UPC 0 72470 00000 2), 6 count boxes (UPC 0 72470 00206 8), Single served (UPC 004-06149-001).
Krispy Kreme Doughnuts Choc Iced Glazed, 2 count boxes (UPC 0 72470 00003 3), 6 count boxes (UPC 0 72470 00226 6), Single served (UPC 004-01155-001).
Krispy Kreme Doughnuts Choc Iced Kreme Filled, 2 count boxes (UPC 0 72470 01702 4), 6 count boxes (UPC 0 72470 00221 1), Single served (UPC 004-06142-001).
US: AL, FL, TX, WI, VT, NC, VA, TN, WA, CA, OH, MO, IL
Plastic Heart Tubes with Chocolate Lentils, Net Wt. 1.7oz (48g), UPC 0-73563-00805-9, 24 count tubes per case
Bee International is recalling Plastic Heart Tubes with Chocolate Lentils because they may contain undeclared milk protein.
Worldwide Distribution in Great Britain, Ireland, and Japan only.
.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter.     .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter.     These guide wires are an orthopedic manual surgical instrument.
24 units of .045 X 6 ST Guide Wire and 25 units of .054 X 7 ST Guide Wire
Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis- packaged as .045 X 6 guide wires.  There is a possibility that using the incorrect guide wire size can cause health hazards, such as mal or nonunion, need for revision surgery, and histological response (if wire breaks).
.045 X 6 ST Guide Wire Lot number: 391681   .054 X 7 ST Guide Wire Lot number: 391680
Blood products collected from a donor  for whom deferral screening was incorrectly performed, where distributed.
OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
OEC FlexiView 8800 systems that had NEMA 5-15 15 Amp power cords replaced between January 28, 2016 and November 23, 2016.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood products, collected from a donor for whom donor screening was incorrectly performed, were distributed.
Lifesouth Community Blood Centers - Montgomery Region
Platelet product, for which quality control and distribution of product did not meet specifications, was distributed.
Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.
Lot Number: 10AFFQ21 Expiration Date: 2021-11-28
Nachmans Native Seafood Smoked Fish spread in 1/2-pound, 5 pounds, and 7.5 pounds plastic containers)
The product contained undeclared wheat in Soy Sauce ingredient.
Blood products, collected from a donor who was previously deferred due to history, were distributed.
Artis Zee and Zeego fluoroscopic x-ray system
2158 units distributed in US and 6,139 worldwide
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
Artis Q and  Q.Zen fluoroscopic x-ray system
2,158 units distributed in US and 6,139 units worldwide
2,158 units distributed in US and 6,139 worldwide
Blood product, which was not quarantined after receiving post donation information concerning an illness following donation, was distributed.
GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21
19,393 cartons (581,790 extended release tablets)
Failed dissolution specifications: Glipizide 2.5 mg ER  Tablets exceeded  dissolution specification rates for the 10 hour testing point.
Inion GRT Tack, drill  bit and tack appl., 4x, Sterile.    Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.
Aluminum pouch seal was noticed to be defective (slightly open).
Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road, Lincolnton, NC 28092.
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Blood products, collected from a donor for whom  eligibility screening was performed incorrectly, were distributed.
Blood components, not manufactured according to specifications, were distributed.
USA (nationwide ) Distribution to medical facilities. Government distribution was also made.  There was no foreign or military distribution.
iConnect Enterprise Archive when used with RadSuite.  The firm name on the label is Merge Healthcare.
187 sites potentially have the affected versions
iConnect Enterprise Archive versions 5.30.0 thru 9.4.3 and V11.0.
Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466
Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%
Blood product, in which donor suitability was not adequately determined, was distributed.
Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric  Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1