Class II · Moderate risk Ongoing
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare…
Reason Presence of a foreign substance.
FDA Drug Recalls
676 recalls · Class II, newest first
Class II · Moderate risk Ongoing
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare…
Reason Presence of a foreign substance.
Class II · Moderate risk Ongoing
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl…
Reason Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and…
Class II · Moderate risk Ongoing
Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC…
Reason Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and…
Class II · Moderate risk Ongoing
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87)…
Reason Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…
Class II · Moderate risk Ongoing
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation…
Reason Discoloration
Class II · Moderate risk Ongoing
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals…
Reason CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II · Moderate risk Completed
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets…
Reason Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and…
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd…
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd…
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd…
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd…
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
Class II · Moderate risk Ongoing
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC…
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
Class II · Moderate risk Ongoing
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing…
Reason Temperature Abuse
Class II · Moderate risk Ongoing
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd…
Reason Discoloration
Class II · Moderate risk Terminated
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA…
Reason Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe…
Reason CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited…
Reason Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the…
Class II · Moderate risk Ongoing
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa…
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · Moderate risk Ongoing
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa…
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · Moderate risk Ongoing
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx…
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · Moderate risk Ongoing
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2…
Reason CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II · Moderate risk Ongoing
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2…
Reason CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II · Moderate risk Ongoing
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal…
Reason CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class II · Moderate risk Ongoing
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal…
Reason CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.