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.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIMethylprednisolone 1% PF Ophthalmic, 3 mL Droppers, 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 1 mg/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 IIMethionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine 10 mg, benzyl alcohol/ water, 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 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL, 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/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, 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 10,000 U/Bupivacaine 0.5% 10 mL, Sodium Bicarbonate 8.4% 50 mL, 61 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 IIHeparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 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 IIHeparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27 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 IIHCG 40 Day Injection Extra Strength, vials, 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 4,100 Units/vial Injection, 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 23 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-8890
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIHCG 20,000 units/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 20 Day Extra Strength, 3500 Units/4 mL, 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 IIHCG 30 Day, 3750 Units/6 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-8890
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIHCG 23 Day, 2876 Units/4.6 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 20 Day Injection, 2625 Units/4 mL, 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 11,000 Units, 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 IIHCG 1,000 U/mL 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 IIGentamicin 250 mg/1000 mL Irrigation, 1000 mL, 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 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 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 IIEstradiol Cypionate 10 mg/mL, 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 IIDMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 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 IIDexamethasone 24 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 IIVancomycin 125 mg/3mL Inhalation, 3 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 IIAmphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIAtropine 0.01% Eye Drops, 1 mL and 2 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 IIAcetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugIso-Tex Diagnostics, IncClass IIVolumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
- 2019-04-24FDA-DrugDr. Reddy's Laboratories, Inc.Class IIDivalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
- 2019-04-24FDA-DrugEstee Lauder IncClass IIIRepairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a 50 mL silver jar with a silver cap, Clinique Laboratories, Dist. New York, NY 10022
Defective container: Ineffective seal between the cap and jar of the affected product.
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