FDARecalled Dec 11, 2024 · #D-0095-2025
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.
Hazard
Class II — temporary health risk
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cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Classification: Class II Distribution: Nationwide in the USA
Product details
- Product
- 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.
- Type
- Drugs
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Model numbers
- 17222470
- UPCs
- —