FDA Recall D-0472-2024
Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ
Class II Ongoing 757 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Reason for recall
Failed Dissolution Specifications
Recall record
- Recall number
D-0472-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA.
- Recall initiated
- 2024-04-17
- Classified by FDA Center
- 2024-04-25
- FDA published
- 2024-05-01
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Firm location
- Mahwah, NJ
Drug identification
- Brand name(s)
- DILTIAZEM HYDROCHLORIDE
- Generic name(s)
- DILTIAZEM HYDROCHLORIDE
- Manufacturer(s)
- GLENMARK PHARMACEUTICALS INC., USA
- NDC(s)
68462-562, 68462-850, 68462-851- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.