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.
- 2019-05-01FDA-DrugCMC Enterprise PharmacyClass IIClindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Lack of sterility assurance.
- 2019-05-01FDA-DrugCMC Enterprise PharmacyClass IIDexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Lack of sterility assurance.
- 2019-04-24FDA-DrugJohnson Matthey Inc.Class IIIRemifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container, Rx ONLY, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742.
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
- 2019-04-24FDA-DrugBrian P. RichardsonClass IKopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- 2019-04-24FDA-DrugTeva Pharmaceuticals USAClass IIAmoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.
Subpotent Product: assay results for Amoxicillin were below the specification limits.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIProstaglandin Tri-Mix 30:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIProstaglandin Tri-Mix 20:25:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIProstaglandin Tri-Mix 8.33:22.5:0.833 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIProstaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIProstaglandin Tri-Mix 5:15:0.5 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIPhenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIPapaverine 30 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIPapaverine 30 mg/Phentolamine 0.5 mg/mL, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIHCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIEstrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIHeparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIGentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIGentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIHeparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IISodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIEDTA 1% Sterile Injection (Preservative Free), Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IILidocaine 1%/Dextrose 12.5% (PF) Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IINeomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution, 1000 mL bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIProstaglandin Tri-Mix 60:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIInterferon 1 Million IU/mL Eye Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IISerum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIMethylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIVitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IITestosterone Cypionate 250 mg/mL Sterile Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIBacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
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