FDAHealthNovember 1, 2024
Glenmark Pharmaceuticals Inc., USA — 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:
⚠️ cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 1, 2024
Nationwide in the USA
What's affected?
- Product
- 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.
- UPC
- 0316714555010
- Lot code
- 17222547
Additional details
Lot #:17222547, Exp. Date, 11/30/2024; 17230598, Exp. Date 02/28/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7296 bottles.
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