Recalls / Class II
Class IID-0472-2024
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 #: 17221312, Exp. 5/31/2024
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Manufacturer
- GLENMARK PHARMACEUTICALS INC., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 3,264 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2024-04-17
- FDA classified
- 2024-04-25
- Posted by FDA
- 2024-05-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0472-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.