Recalls / Class II
Class IID-0096-2025
Product
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.
- Brand name
- Diltiazem Hydrochloride
- Generic name
- Diltiazem Hydrochloride
- Active ingredient
- Diltiazem Hydrochloride
- Route
- Oral
- NDCs
- 16714-553, 16714-554, 16714-555
- FDA application
- ANDA212317
- Affected lot / code info
- Lot #: 17222544, Exp 11/30/2024.
Why it was recalled
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Manufacturer
- Northstar Rx LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 5232 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-11-01
- FDA classified
- 2024-12-03
- Posted by FDA
- 2024-12-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0096-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.