FDAHealthNovember 1, 2024
Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Produc
⚠️ cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 1, 2024
Nationwide in the USA
What's affected?
- Product
- 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.
- UPC
- 0368462562017
- Lot code
- 17222452
Additional details
Lot #s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 12,864 bottles.
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