Recalling Firm
Implant Direct Sybron Manufacturing, LLC
Central Texas Regional Blood & Tissue Center
Creative Contract Packaging Corporation, LLC
Philips Electronics North America Corporation
Oklahoma Blood Institute - Sylvan N Goldman Center
HCSC-Blood Center dba as Miller-Keystone Blood Center

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Nationwide in the USA to hospitals and medical facilities.
USA Distribution to the states of : AL, AZ, CA, CO, FL, GA, IL, MA, MI, MN, MO, NE, NJ, NY, OH, PA, TN, UT, WA.
Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida
Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.
Product was shipped to the following states: NY, OH & PA
Amazon in TX, NY, CO, CA, WA, IL, GA, KS, MA, NJ.
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Europe, Canada, Australia, Egypt, Jordan, and Lebanon.
AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Puerto Rico Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bulgaria, Cambodia, Canada, Cayman Island, Chile, China, Colombia, Congo, Cote D'Ivoire, Cuba, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Papua, Paraguay, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, and Yemen
Colorado; Florida; Virginia; Nebraska; Oklahoma
International Distribution to: Germany, Slovakia and Israel.
US, Canada, France, Italy, Spain, Germany
AR; AT; BE; CH; CN; CZ; DE; ES; FR; GB; GR; HK; IN; IR, IT; KR; MX; NL; NP, PH; PK; PL; TR, TW; US; UY, VN
US Distribution to the states of : FL, LA, IL, CA, MO, MN, TX, OK, TN, and NY
Worldwide Distribution - USA (nationwide) and to the countries of : Algeria, Austria, Australia, Belarus, Bosnia-Herz., Canada, Croatia, Czech Republic, Egypt, Estonia, France, Georgia, Germany, Greece, Guam, Hong Kong, Hungary, India, Israel, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Netherlands, Nigeria, Peru, Philippines, Qatar, Russian Fed., Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Utd.Arab Emir.
Domestic: AZ, CA, CO, CT, DE, IA,ID, IN, MN, NC, GA, OR, PA, NY, WI, WA, MA, TX, FL, GA, VA, NH Foreign:None VA/DOD:None
Florida, California and one customer each in Mexico, Canada and Columbia, Also online sales
20 units affected. 18 domestic, 2 foreign.
Domestic: OH, IN, WI, NY, MI, IL, MD, CT, GA, FL, TX No foreign or VA/DOD
Worldwide distribution. Australia, Austria, Bahrain, Belgium, Brazil, Denmark, France, French Polynesia, Germany, Hong Kong, India, Ireland, Israel, Italy, Kenya, Lebanon, Lesotho, Malaysia, Maldives, Morocco, Netherlands, Oman, Pakistan, Palestine, Poland, Saudi Arabia, South Africa, Spain, Sweden, Thailand, Turkey, United Kingdom, UAE, Vietnam, and Zimbabwe.
Worldwide Distribution - USA (nationwide) Distribution.
Pennsylvania; New York; New Jersey; Florida; Maryland

Product Description
Lund's & Byerly's Chipotle Ranch flavored Potato Chips, 8 oz., UPC 72431-009792.
Cheddar & Sour Cream flavored Potato Chips packaged under the following brands and sizes: 1. Old Dutch Ripples, 2 oz, UPC 74690-024066; 8 oz., UPC 74690-230290; and 15.5 oz., UPC 74690-205694. 2. Old Dutch Rip-L Family Pack, 9.5oz, UPC 74690-201160 3. Roundy's, 2 oz, UPC 11150-041430; 10.5 oz, UPC 11150-224826; and 15.75 oz, UPC 11150-224536. 4. Urge, 2.5 oz, UPC 39779-014369; and 6 oz, UPC 39779-012617
Urge Ranch flavored Tortilla Chips, 8 oz., UPC 39779-013126.
Old Dutch Ripples French Onion flavored Potato Chips, 2 oz., UPC 74690-023670, and 8 oz. UPC 74690-230160.
Jalapeno Popper flavored Potato Chips packaged under the following brands and sizes: 1. Old Dutch Ripples, 3 oz, UPC 74690-028590; and 8 oz., UPC 74690-231556. 2. Roundy's, 10.5 oz, UPC 11150-224499.
I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
***WATSON LAMB SUPPLEMENT for Growing Sheep*** Bulk or 50 lbs. (22.68 kg) Net Weight***Manufactured By: CHS Inc., Sioux Falls, SD 57107*** www.chsinc.com
Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men greater or equal to 50 years of age with a prostate volume greater than or equal to 30cm3 and less than or equal to 80cm3. The Rezum System is also indicated for treatment of prostates with hyperplasia of the central zone and/or a median lobe.
LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.
NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.
Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84
Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15
Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02
Primera Negra, Artificial Vanilla Flavoring NET WT 4 OZ and 8 OZ
Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
All Natural Dark Chocolate Covered Raisins INGREDIENTS: Dark Chocolate (Sugar Chocolate Liquor, Cocoa Butter, Chocolate Liquor Processed W/Alkali, Soy Lecithin (An Emulsifier), Vanilla, Salt,), raisins And Confectioners Glaze. DIST BY THE KROGER CO CINCINNATI, OHIO 45201
All Natural Dark Chocolate Covered Ginger INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, CHOCOLATE LIQUOR PROCESSED WITH ALKALI, SOY LECITHIN (EMULSIFIER), SALT, VANILLA), GINGER (DICED/SLICED GINGER, SUGAR) AND CONFECTIONERS GLAZE. DISTRIBUTED BY THE KROGER CO CINCINNATI, OHIO 45201
All Natural Dark Chocolate Covered Almonds INGREDIENTS: Natural Dark Chocolate (Sugar Chocolate Liquor, Cocoa Butter, Chocolate Liquor Processed W/Alkali, Soy Lecithin (An Emulsifier), Vanilla, Salt,), Almonds And Confectioners Glaze. DIST BY THE KROGER CO CINCINNATI, OHIO 45201
All Natural Dark Chocolate Covered Pretzel Balls INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, CHOCOLATE LIQUOR PROCESSED WITH ALKALI, SOY LECITHIN (EMULSIFIER), SALT, VANILLA), PRETZEL BALLS (ENRICHED WHEAT FLOUR (WHEAT FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIVE ACID), SALT, VEGETABLE OIL (CONTAINS ONE OR MORE OF THE FOLLOWING: CANOLA OIL, CORN OIL, SOYBEAN OIL), MALT, LEAVENING (CONTAINS ONE OR MORE OF THE FOLLOWING YEAST, SODIUM BICARBONATE, AMMONIUM BICARBONATE) AND CONFECTIONERS GLAZE. DISTRIBUTED BY THE KROGER CO CINCINNATI, OHIO 45201
All Natural Dark Chocolate Covered Coffee Beans INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, CHOCOLATE LIQUOR PROCESSED WITH ALKALI, SOY LECITHIN (AN EMULSIFIER), VANILLA, SALT, AND ARTIFICIAL FLAVORING ADDED), DRY ROASTED COFFEE BEANS AND CONFECTIONERS GLAZE DIST BY THE KROGER CO CINCINNATI, OHIO 45201
All Natural Dark Chocolate Covered Cranberries INGREDIENTS: DARK CHOC (SUGAR, CHOC LIQUOR, COCOA BUTTER, SALT, VANILLA) CRANBERRIES, CONFECTIONERS GLAZE. DIST BY THE KROGER CO CINCINNATI, OHIO 45201
Gia Russa Spaghetti Dinner Sauce TRADITIONAL NET WT. 1 Lb. 8 oz (24 oz) 680 grams INGREDIENTS: Tomato Puree***Canola Oil, Sugar, Modified Food Starch, Salt, Garlic, Onions, Citric Acid, Oregano, Basil Distributed By: Gia Brands Inc., Boardman, OH 44512 UPC 0 26825 00832 8
Gia Russa Spaghetti Dinner Sauce Mushrooms NET WT. 1 Lb. 8 oz (24 oz) 680 grams INGREDIENTS: Tomato Puree***Canola Oil, Sugar, Modified Food Starch, Salt, Mushrooms, Garlic, Onions, Citric Acid, Oregano, Basil Distributed By: Gia Brands Inc., Boardman, OH 44512 UPC 0 26825 00830 4
Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249
Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India
Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by Perrigo, Allegan, MI 49010, NDC 70085-151-01
Apheresis Platelets, Leukocytes Reduced, Irradiated
Happy Belly Cranberry & Nuts Trail Mix - dried cranberries, cashews and almonds. 16 oz. (454 g); Allergens: almonds, Cashews UPC 48719 09587 Cranberry & Nuts Trail Mix - Dried cranberries (cranberries, sugar, sunflower oil), cashews, almonds, vegetable oil (may contain one or more of the following: peanut, canola, sunflower and/or soybean oil), sea salt.. Allergens: Almonds and cashews
Happy Belly Deluxe Mixed Nuts - roasted and salted with sea salt. Cashews, Almonds, Brazil nuts, pecans & Hazelnuts 16 oz. (454 g); Allergen information: contains Milk, Almonds, Wheat, Peanuts. UPC 48719 09577 Cranberry & Nuts Trail mix has dried cranberries, cashew & almonds. Allergen information: Almonds and cashews
Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.
Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28
DARK CHOCOLATE CRANBERRY, 16 oz., 25 pound bulk case
DARK CHOCOLATE CHERRY, 16 oz., 25 pound bulk case
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm; UPN M0033PK42022002 Stroke intervention kit
Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit
Pre-starter 12/15 Complete Pellet with Chlortetracycline and Denagard (Tiamulin); Type C Feed; labeled to contain 400 g CTC and 35 g Tiamulin; packaged in 50 lb. bags.
HERB-OX Beef Flavor Granulated Bouillon, 4 ounce jars
Radiant Colors Victor Portugal Lining Black; 1 oz. plastic bottle Manufactured by Radian Colors Inc. 6601 Hollywood Blvd. Los Angeles, CA 90028
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Choceur Dark Chocolate Bars, 5.29 oz., 20 units/case
3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation and reducing wound healing time on the calf.
Sensations cinnamon roll UNCOOKED DOUGH 450g, UPC: 236821197
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
Raley's All Butter Meyer Lemon Cookie; Case of Raw Dough (168 cookies) 28.87 lbs - UPC 10659728; 1 cookie (85 g); 6 count package UPC 4656760890 sold in retail stores Individual cookies in Bakery Case - identifier 106 Ingredients: ENRICHED BLEACHED WHEAT FLOUR (WHEAT FLOUR, NIACIN, IRON, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID), SUGAR, BUTTER (PASTEURIZED CREAM), WHOLE EGGS, WATER, MEYER LEMON JUICE CONCENTRATE, VANILLA EXTRACT, SEA SALT, BAKING POWDER (SODIUM ACID PYROPHOSPHATE, SODIUM BICARBONATE, MODIFIED FOOD STARCH, MODIFIED TAPIOCA, MONOCALCIUM PHOSPHATE), MODIFIED FOOD STARCH, MILK POWDER, INVERT SUGAR, BAKING SODA, NATURAL LEMON FLAVOR Contains: WHEAT, MILK, EGG
SPRINGFIELD SMOKED FISH PRE-SLICED SMOKED SALMON CRAFTED BY ARTISANS HAND CUT AND PACKED, 1 Lb. Presliced Nova. UPC: 8 11907 01801 8.
Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures ( such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP) Non-vascular interventions such as drainages, biopsies and vertebroplastics procedures The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
Red Blood Cells, Leukocytes Reduced, Irradiated

Reason for Recall
Products were made with a seasoning component that contains a milk ingredient that has the potential to be contaminated with Salmonella.
Activity and quantity of seeds sent in shipments were incorrect.
Subpotent Drug: found to be below the specification for labeled assay.
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Watson Lamb Supplement non-medicated sheep feed, bulk pellets, is recalled due to high level of copper.
Needle Bond may not be able to withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue to deliver treatments.
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Presence of Particulate Matter: glass particulate found in vial
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.
The products may contain an undeclared milk allergen.
Microbial Contamination of Non-Sterile Products
Plateletpheresis products, not meeting product specifications, were distributed.
Firm was notified by customer that the back panel (ingredients and nutrition facts) was incorrect on three snack mixes. Principal display label is correct which shows the main ingredients (allergens).
The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that will not allow the 3.4 drill to pass through, since the diameter is too small. In addition, the 2.3mm guide was too large.
Intermittent communication between the host system and the FlexCardio
printed on the blister foil and package insert, however,all tablets are active.
Rocky s Historic Eastern Market initiated a voluntary recall of DARK CHOCOLATE CHERRY, and DARK CHOCOLATE CRANBERRY due to undeclared allergen milk following a supplier's recall.
Rockys Historic Eastern Market initiated a voluntary recall of DARK CHOCOLATE CHERRY, and DARK CHOCOLATE CRANBERRY due to undeclared allergen milk following a supplier's recall.
Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
Medicated feed labeled to contain chlortetracycline (CTC) and tiamulin. Testing revealed the feed was subpotent for CTC and also contain oxytetracycline which is an unapproved drug combination.
Blood product, labeled as leukoreduced but failed quality control testing for WBC count, was distributed.
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.
Creative Contract Packaging LLC is voluntarily recalling two code dates of HERB-OX Beef Flavor Granulated Bouillon, due to the potential presence of an undeclared milk allergen.
Tattoo ink found to contain Bacillus altitudinis
Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram).
Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem.
Platelet product, for which unit sterility was compromised during collection, was distributed.
ALDI has voluntarily recalled Choceur Dark Chocolate Bars due to the potential presence of almond pieces, which are an undeclared treenut allergen.
3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
Platelet products, not prepared in accordance with specifications, were distributed.
Product contains undeclared pecans. Pecans are clearly visible to the consumer.
Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM.
Plastic material was found in unbaked Meyer Lemon Cookies at retail store.
Product tested positive for Listeria monocytogenes.
When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurements performed using the QA Basic Measurement tool will not be correctly exported to the external DICOM destination.
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Human corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.
Blood products, lacking assurance of proper temperature storage, were distributed.

Code Info
Product Code: 1251QCSCE, Lot No. BBAY0072, BBAY0079, BBAY0090, BBAY0071, BBAY0073.
5065.U02 88040417 M477780. The lot code is interpreted as: 5065.U02 product code. 88 is the plant number. 040417 is the date of production. M477780 is the lot code ID.
UDI 08855757006010. Lot Number of Outside Cases (Pack Lot) 2017020920 with Lot Number of Inside Boxes (Product Lot) 2017011612 and Exp Date 2018-01-31: Lot Number of Outside Cases (Pack Lot) 2017030286 with Lot Number of Inside Boxees (Product Lot) 2017011187 and Exp Date 2018-01-31.
PLU 90763 - All products purchased on or before 10/30/2017
PLU 90532 - All product purchased on or before 10/30/2017
PLU 90062 - All product purchased on or before October 30, 2017.
PLU 50862 - All products purchased on or before 10/30/2017
PLU 54166 - All product purchased on or Before 10/30/2017
PLU 54183 All product purchased on or before 10/30/2017
Distributed between 7/15/2016 to 10/30/2017, there are no lot codes or UPC codes
Lot Number QPC30200039, Exp. Date 28-Aug-18; QPC30200114, Exp. Date 28-Mar18
Lot Number QX10100894. Exp. Date 28-Oct-18
Lot Numbers: QXC10200044, exp. date 28-Aug-18; QXC10200043, exp. date 28-Aug-18
dates of SEPT 2020 and OCT 2020. The code date is located on top of the lid.