Recalls / Class II
Class IID-0430-2024
Product
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01
- 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 #: 17230304, Exp. 12/31/2024.
Why it was recalled
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
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
- 6,528 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2024-03-26
- FDA classified
- 2024-04-02
- Posted by FDA
- 2024-04-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0430-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.