Why it was recalled
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 17230304, Exp. 12/31/2024.
Where it was sold
Nationwide in the US
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-0430-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 26, 2024
- FDA report date
- Apr 10, 2024
- Quantity
- 6,528 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0430-2024, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94280
- Address
- 750 Corporate Dr
- Code information
- Lot #: 17230304, Exp. 12/31/2024.
- Postal code
- 07430-2009
- Report date
- Apr 10, 2024
- Product type
- Drugs
- Recall number
- D-0430-2024
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 6,528 bottles
- Reason for recall
- Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Mar 26, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 2, 2024