FDA Recall D-0430-2024

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 779 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

Lot / code: Lot #: 17230304, Exp. 12/31/2024.

Quantity: 6,528 bottles

Reason for recall

Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.

Recall record

Recall number: D-0430-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the US
Recall initiated: 2024-03-26
Classified by FDA Center: 2024-04-02
FDA published: 2024-04-10
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.

‹ All recalls