MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; vitility@yahoo.com; www.manofsteelpills.com; UPC 1 0001001378 7.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
China  France  Italy  Kuwait  Spain  Turkey  United States
Power Processor 1K Stockyard.    The Power Processor performs all pre-analytical sample tube  preparation.
Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard  can initiate a retrieval of a sample tube during the rack loading process, which should not  occur. This issue and associated complaint were discovered and filed internally.
US Nationwide and the countries of Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands, Poland, Sweden, Thailand, Colombia, India, South Africa, United Arab Emirates.
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO  Catheter has had a separation of the clear extension tube from the hub connection. These  adverse events resulted in patient injury (blood loss).
PIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, Manufactured By: Jimin Pharmaceutial Co., LTD., Distributor: Lucky Mart, El Monte, CA  91733, NDC 68085-8012-4.
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-03
Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-239-01
Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-242-01
Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-245-02
Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-03
Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-245-03
Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-243-03
Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-01
Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478,  NDC# 71019-242-02
Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-245-04
Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-243-04
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag  Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-05.
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-06
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-04
Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-243-01
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution was made to medical facilities located in CA, FL, GA, LA, NY, PA, and TN.  There was government distribution but no foreign/military distribution.
Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.
The torque wrench used to tighten system bolts during installation was found to be out of tolerance
Symbia T2 serial number 2001; Symbia Intevo Excel serial numbers 2112 and 2140; Symbia Intevo 16 serial numbers 2100 and 2116; Symbia Evo serial numbers 1049, 1054, 1071, 1075, 1104, and 1128; and Symbia Evo Excel serial numbers 1109, 1111, 1131, 1134, and 1158.
Worldwide Distribution - USA (nationwide)  to medical facilities, and to the countries of :  Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland,  Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, United Arab Emirates, and Viet Nam.    There was no military/government distribution.
Oncentra Brachy 4.5 radiation therapy software  The firm name on the label is Nucletron B.V.    Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.
89 customer sites have the affected software
Incorrect source step size may occur in the software plans
US Distribution to states of: NY, FL CA, NC, TX and NJ.
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation     Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
(Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining devices in the U.S. until supporting clinical data can be submitted and evaluated by FDA.
Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) NDC# 4903594126 UPC# 681131150774 Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716; Studio 35 Beauty Daily Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) NDC# 0363001726 UPC# 049022889125 Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015
Out of specification results for stability shelf life.
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE.     The GORE TAG Thoracic Endoprosthesis is intended  for endovascular repair of all lesions of the descending  thoracic aorta.
Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.
Worldwide Distribution - US (nationwide including Puerto Rico) Internationally to New Zealand, Brazil, India, Philippines, Nicaragua, Argentina, Australia, Chile, Viet Nam, Colombia, Pakistan, Malaysia, Dubai, Germany, Hong Kong, Bangladesh, Uruguay Thailand, China, Saudi Arabia, Taiwan, Honduras, Ecuador, Kuwait, South Korea, and Costa Rica
Sysmex Fluorocell(R) PLT   Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
Diet Rite, Pure Zero Cola, 0 calories, 0 caffeine, 0 sodium, Bottled under the authority of Dr. Pepper/Seven up Inc. Plano TX. packed in 2 liter bottles, 0.5 liter bottles, and 12 oz cans.
2 liters: 4,692 cases; 0.5 liters: 1,978 cases; 12 oz cans 9,184 cases
Product is labeled to be caffeine-free but contains caffeine.
Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.
Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
Apheresis Red Blood Cells, Leukocytes Reduced
Blood products, collected using instruments that had not been validated following repair, were distributed.
EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE      Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE      Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
U.S. distribution to the following: GA, TX, MN, CA, AZ, TX, MN, NY, and IL.    No foreign distribution.
Instant Reishi Coffee, 4 in 1;  Ca Phe Ling Chi;  20 sachets, Net Wt. 360g (12.7 oz.)  UPC 8 93663 00225 8  Ingredients: Sugar, Non Dairy Creamer, Instant Coffee, Reishi Extract.    Chun Yuen Trading, So. El Monte, CA
Milk is not declared on the product labeling.
ENLIGHTENED THE GOOD-FOR-YOU ICE CREAM 60 CALORIES PER SERVING PINA COLADA MORE PROTEIN. LESS SUGAR 1 PINT LOW FAT ICE CREAM, UPC 8 52109 33108 6. KEEP FROZEN.
US, Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific
BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm.    The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to Prime, Failure to Fire, Failure to Obtain Sample, and Self-Activation.
OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only,  Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025000101
Norepinephrine Bitartrate  8 mg added to 0.9% Sodium Chloride 250 mL in a bag,  Rx Only,  Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011501
ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride,  Rx Only,  Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025024801
VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025007001
Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only,  Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025014801
Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601
Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025016201
Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags,  Rx Only,  Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025003201
Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette  Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301
Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226,  NDC 7025088801
fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011001
VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only,  Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025002501
Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only,  Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001.
fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025011001
Nationwide throughout the US and via amazon.com
365 Organic Raisin Bran Flakes 15 oz. packaged in plastic bag, then cardboard box
Undeclared (peanut) allergen: 365 Organic Peanut Butter and Cocoa Balls were packaged into 365 Organic Raisin Bran Flakes boxes.
Product was distributed in Michigan, Kentucky, Tennessee and Georgia.
GREAT AMERICAN DELI PREMIUM CHICKEN SALAD WHEATBERRRY sandwiches are packaged in a flexible plastic containers, NET WT. 6.4 oz (181g), Great American Deli, PO Box 27, Ooltewah, TN 37363 UPC 7 41431 00228 6
Product contains undeclared eggs and soy.
Cascadian Farm Organic Cinnamon Raisin Granola, Net Wt 15.6 oz  (442g).  UPC 21908-74329
General Mills is recalling 2 production runs of Cascadian Farm Organic Cinnamon Raisin Granola due to undeclared nut allergen, almond.
Better if Used by:  20MAR2018, and 21MAR2018
SKU 57879, Trader Joe's Organic Tomato & Roasted Red Pepper Soup, packaged in a Tetra Pak aseptic container/carton.  There are 12 cartons per case.  Net Wt. 32 fl. oz.  UPC 00578790.     Item # 52603-05405, Pacific Organic Roasted Red Pepper and Tomato Soup Canadian, packaged in a Tetra Pak aseptic container/carton.  There are 12 cartons per case. Net Wt. 32 fl. oz.  No UPC.
160 cases or 1,920 cartons total (Trader Joe's = 10 cases (120 cartons); Pacific = 150 cases (1,800 cartons)
Product is recalled due to potential under processing.
Trader Joe's: BEST IF USED BY:   01AUG18 PFO 17213-5    Pacific (Canadian): BEST BEFORE:   01AUG18 PFO 17213-14
Blood product, collected from a donor taking the medication Propecia, was distributed.
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA  92880 USA, NDC 0591-5884-01.
Failed Dissolution Specifications: Low out of specification results for dissolution.
Weis, Sunbury, PA;  BLT Sandwich;   1 CT
The firm is recalling their Store Made BLT sandwich due to undeclared egg found in the mayonnaise ingredient. The firm received an illness complaint reporting that egg was not declared in the mayonnaise ingredient.
Kenny's Buckeye Pie, Net Wt.22 oz. (624g).
Thanlwin Fried Bean Snack, Net Weight 227 g 8 oz..  UPC 84682-00095 Product of Myanmar.
Thanlwin Fried Bean Snack is being recalled due to undeclared peanuts.