Recalls / Class II
Class IID-0094-2025
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.
- Brand name
- Diltiazem Hydrochloride
- Generic name
- Diltiazem Hydrochloride
- Active ingredient
- Diltiazem Hydrochloride
- Route
- Oral
- NDCs
- 68462-562, 68462-850, 68462-851
- FDA application
- ANDA212317
- Affected lot / code info
- Lot #s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025
Why it was recalled
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Manufacturer
- GLENMARK PHARMACEUTICALS INC., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 12,864 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-11-01
- FDA classified
- 2024-12-03
- Posted by FDA
- 2024-12-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0094-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.