FDAFDA · Food and drugs·Recall number D-0430-2024
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
Published April 10, 2024 · Recall initiated: March 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DILTIAZEM HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Nationwide in the US
- UPC
- 0368462562017
- Lot
- Lot #: 17230304, Exp. 12/31/2024.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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