Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by…
Reason CGMP Deviations
FDA Drug Recalls
778 recalls, newest first
Class II · Moderate risk Ongoing
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets(…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya…
Reason CGMP Deviations