Why it was recalled
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 17222544, Exp 11/30/2024.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0096-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 1, 2024
- FDA report date
- Dec 11, 2024
- Quantity
- 5232 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0096-2025, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95660
- Address
- 750 Corporate Dr
- Code information
- Lot #: 17222544, Exp 11/30/2024.
- Postal code
- 07430-2009
- Report date
- Dec 11, 2024
- Product type
- Drugs
- Recall number
- D-0096-2025
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 5232 bottles
- Reason for recall
- cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 1, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 3, 2024