Class II
Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, 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 16714-555-01.
This recall is currently active, issued December 11, 2024. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- November 1, 2024
- Posted
- December 11, 2024
- Recall Number
- D-0098-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 7296 bottles
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #:17222547, Exp. Date, 11/30/2024; 17230598, Exp. Date 02/28/2025
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