Class II
Ongoing
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
This recall is currently active, issued April 10, 2024. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- March 26, 2024
- Posted
- April 10, 2024
- Recall Number
- D-0430-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6,528 bottles
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide in the US
Lot / Code Info
Lot #: 17230304, Exp. 12/31/2024.
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