D-0430-2024 Class II Ongoing
FDA drug recall D-0430-2024 was initiated by Glenmark Pharmaceuticals Inc., USA on Mar 26, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 6,528 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 10, 2024
- Initiation Date
- Mar 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,528 bottles
Product Description
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: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Distribution Pattern
Nationwide in the US
Code Information
Lot #: 17230304, Exp. 12/31/2024.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0430-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026