Category
Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-09-21FDA-DrugSUPERIOR GLOVE WORKS, LTD.Class IISynergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are not available, Alcohol 80% Topical Solution, Antiseptic, 8.5 oz./ 250 mL bottles, Made and Distributed by: Superior Glove Works Ltd., 36 Vimy Street, Acton, Ontario, L7J 1S1, Canada, Made in Canada, UPC: 779406201594.
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
- 2022-09-21FDA-DrugLupin Pharmaceuticals Inc.Class IILisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
- 2022-09-21FDA-DrugDirect RxClass IITriamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
- 2022-09-21FDA-DrugCarolina InfusionClass IIQUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IIQUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IITRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IITRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IITRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IITRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IITRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IITRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IITRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IITEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IITEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IITEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IITEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IISemaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IISemaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IISemaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IISermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IIMIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IIMIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugCarolina InfusionClass IIL-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugPine Pharmaceuticals, LLCClass IIBupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Parkway, Tonawanda, NY 14150.
Lack of Assurance of Sterility
- 2022-09-21FDA-DrugVi-Jon, LLCClass IIMagnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 66220 4 Proudly Distributed By: Valu Merchandisers, Co. 5000 Kansas Ave Kansas City, KS 66106; b) CVS Health UPC 0 50428 30745 8 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, CVS Health UPC 0 50428 32503 2 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; c) Equate NDC 49035-592-38 UPC 6 81131 28715 9 Distributed By: Walmart, In
CGMP Deviations;
- 2022-09-21FDA-DrugVi-Jon, LLCClass IIMagnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 58790 3 Proudly Distributed By: Valu Merchandises, Co. 5000 Kansas Ave. Kansas City, KS 66106; b) Careone UPC 3 41520 00055 3 Distributed By: Foodhold U.S.A., LLC, Landover, MD 20785, Careone UPC 3 41520 00055 3 Distributed By: Adusa Distribution, LLC Salisbury, NC 28147; c) CVS Health UPC 0 50428 29733 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
CGMP Deviations
- 2022-09-21FDA-DrugVi-Jon, LLCClass IIMagnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), a) CVS Health UPC 0 50428 33517 8 or UPC 0 50428 30594 2 Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; b) Best Choice UPC 0 70038 20049 9 Proudly Distributed By: Valu Merchandisers, Co. 5000 Kansas Ave Kansas City, KS 66106; c) Care One UPC 3 41520 31322 6 Distributed By: Foodhold U.S.A., LLC, Landover, MD 20785 or Distributed By: Adusa Distribution, LLC Salisbury, NC 28147;
CGMP Deviations
- 2022-09-21FDA-DrugVi-Jon, LLCClass IWalgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Grape Flavor, 10 FL OZ (296 mL), Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015; NDC 0363-7162-38 UPC 3 11917 20159 7 (purple label).
Microbial contamination of non-sterile products.
- 2022-09-21FDA-DrugVi-Jon, LLCClass IWalgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8166-38 UPC 3 11917 20160 3 (green label)
Microbial contamination of non-sterile products.
- 2022-09-21FDA-DrugVi-Jon, LLCClass ITopcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Cherry Flavor, 10 FL OZ (296 mL), Distributed By Topco Associates LLC Elk Grove Village, IL 60007; NDC 36800-164-38 UPC 0 36800 45530 6
Microbial contamination of non-sterile products.
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