December 25, 2024DrugsFDA
Macleods Pharmaceuticals Ltd recalls Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 0854
Hazard: Failed Impurities/Degradation Specifications
December 25, 2024DrugsFDA
Regenerative Processing Plant, LLC recalls PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; M
Hazard: Lack of Sterility Assurance
December 25, 2024DrugsFDA
Regenerative Processing Plant, LLC recalls LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactur
Hazard: Lack of Sterility Assurance
December 25, 2024DrugsFDA
Apothecus Pharmaceutical Corp. recalls VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By:
Hazard: CGMP deviations: out of specifications for assay
December 25, 2024DrugsFDA
Provepharm Inc. recalls Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm
Hazard: Discoloration
December 25, 2024DrugsFDA
Aurobindo Pharma USA Inc recalls Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightst
Hazard: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
December 25, 2024DrugsFDA
Keystone Industries recalls Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melvi
Hazard: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
December 25, 2024DrugsFDA
Keystone Industries recalls Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
Hazard: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
December 25, 2024DrugsFDA
Keystone Industries recalls Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Den
Hazard: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
December 25, 2024DrugsFDA
Keystone Industries recalls safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Glut
Hazard: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
December 25, 2024DrugsFDA
Keystone Industries recalls Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactu
Hazard: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
December 25, 2024DrugsFDA
Keystone Industries recalls Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply
Hazard: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
December 25, 2024DrugsFDA
Keystone Industries recalls Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
Hazard: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
December 25, 2024DrugsFDA
Keystone Industries recalls Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patter
Hazard: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
December 25, 2024DrugsFDA
Keystone Industries recalls Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental C
Hazard: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
December 25, 2024DrugsFDA
Keystone Industries recalls Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Pro
Hazard: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
December 25, 2024DrugsFDA
Keystone Industries recalls M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Su
Hazard: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
December 25, 2024DrugsFDA
Keystone Industries recalls Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Demo
Hazard: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
December 18, 2024DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets
Hazard: Subpotent and Superpotent Drug
December 18, 2024DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets
Hazard: Subpotent and Superpotent Drug
December 18, 2024DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets
Hazard: Subpotent and Superpotent Drug
December 18, 2024DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets
Hazard: Subpotent and Superpotent Drug
December 18, 2024DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets
Hazard: Subpotent and Superpotent Drug
December 18, 2024DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets ea
Hazard: Subpotent and Superpotent Drug
December 18, 2024DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distri
Hazard: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
December 18, 2024DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distri
Hazard: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
December 18, 2024DrugsFDA
Viatris Inc recalls Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles
Hazard: Superpotent Drug and Subpotent Drug: potency failures obtained
December 18, 2024DrugsFDA
Viatris Inc recalls Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles
Hazard: Superpotent Drug and Subpotent Drug: potency failures obtained
December 18, 2024DrugsFDA
Viatris Inc recalls Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (
Hazard: Superpotent Drug and Subpotent Drug: potency failures obtained
December 18, 2024DrugsFDA
Viatris Inc recalls Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (
Hazard: Superpotent Drug and Subpotent Drug: potency failures obtained