FDA Recall D-0097-2025

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 559 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 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-554-01.

Lot / code: Lot #: 17222452, Exp Date 11/30/2024; 17230607, Exp Date 02/28/2025.

Quantity: 4704 bottles

Reason for recall

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Recall record

Recall number: D-0097-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-11-01
Classified by FDA Center: 2024-12-03
FDA published: 2024-12-11
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): DILTIAZEM HYDROCHLORIDE
Generic name(s): DILTIAZEM HYDROCHLORIDE
Manufacturer(s): Northstar Rx LLC
NDC(s): 16714-553, 16714-554, 16714-555
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.

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