Category
Drug and pharmaceutical recalls
17728 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 IICeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, 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 IILidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, 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 IILidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, 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 IILidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, 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 IIAlteplase 1 mg/mL 1 mL in 10 mL syringe, 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 IIOxytocin 30 units in NS 500 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 IINorepinephrine 16 mg in NS 250 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 IINICARdipine 25 mg in NS 250 mL EXCEL 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 IIMagnesium Sulfate 6 GM 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 IIMagnesium Sulfate 4 GM 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 IIMagnesium Sulfate 2 GM 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 IIMagnesium Sulfate 1 GM 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 IILabetalol 20 mg/4 mL, 20 mg in 4 mL syringe, 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 IIDiltiazem 250 mg in NS 250 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 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.
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