DILTIAZEM HYDROCHLORIDE
Wed Dec 11 2024
1 of 9
Summary
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| Diltiazem 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. | Northstar Rx LLC | Nationwide in the USA | 4704 bottles |
| Diltiazem 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. | GLENMARK PHARMACEUTICALS INC., USA | Nationwide in the USA | 25584 bottles |
| 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. | Northstar Rx LLC | Nationwide in the USA | 7296 bottles |
| Diltiazem 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. | GLENMARK PHARMACEUTICALS INC., USA | Nationwide in the USA | 34848 bottles |
| Diltiazem 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. | Northstar Rx LLC | Nationwide in the USA | 5232 bottles |
| Diltiazem 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. | GLENMARK PHARMACEUTICALS INC., USA | Nationwide in the USA | 12,864 bottles |