FDAFDA · Food and drugs·Recall number D-0096-2025
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, 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 16714-553-01.
Published December 11, 2024 · Recall initiated: November 1, 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
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 17222544, Exp 11/30/2024.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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