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Recall Enforment Report D-0098-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Glenmark Pharmaceuticals Inc., USA, originally initiated on 11-01-2024 for the product Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01. The product was recalled due to cgmp deviations: presence of n-nitroso-desmethyl-diltiazem impurity above fda recommended interim limit.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0098-202511-01-202412-11-2024Class II7296 bottlesDiltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01.cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Ongoing
D-0095-202511-01-202412-11-2024Class II25584 bottlesDiltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Ongoing
D-0097-202511-01-202412-11-2024Class II4704 bottlesDiltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-554-01.cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Ongoing
D-0093-202511-01-202412-11-2024Class II34848 bottlesDiltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01.cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Ongoing
D-0094-202511-01-202412-11-2024Class II12,864 bottlesDiltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Ongoing
D-0096-202511-01-202412-11-2024Class II5232 bottlesDiltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01.cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
16714-553Diltiazem Hydrochloride Diltiazem HydrochlorideCapsule, Extended ReleaseOralNorthstar Rx LlcHuman Prescription Drug
16714-554Diltiazem Hydrochloride Diltiazem HydrochlorideCapsule, Extended ReleaseOralNorthstar Rx LlcHuman Prescription Drug
16714-555Diltiazem Hydrochloride Diltiazem HydrochlorideCapsule, Extended ReleaseOralNorthstar Rx LlcHuman Prescription Drug
68462-562Diltiazem Hydrochloride Diltiazem HydrochlorideCapsule, Extended ReleaseOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-850Diltiazem Hydrochloride Diltiazem HydrochlorideCapsule, Extended ReleaseOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-851Diltiazem Hydrochloride Diltiazem HydrochlorideCapsule, Extended ReleaseOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug