Drug and pharmaceutical recalls
17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIHalobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIHalobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-033-50.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIGentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIGentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIFluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIFluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIFluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIEconazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIDiflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-031-60.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIDiclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIDiclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIDesoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIDesoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIDesoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIDesonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIClobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIClobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIClobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIClobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIClobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIBetamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugBlaine Labs IncClass IREVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
- 2022-03-23FDA-DrugWalmart StoresClass IAvaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIFentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIMethylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IILorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIKetamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIMorphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IIVancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
- 2022-03-23FDA-DrugFamily Pharmacy of StatesvilleClass IITrimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
Lack of Assurance of Sterility
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