Why it was recalled
Failed Dissolution Specifications
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 #: 17221312, Exp. 5/31/2024
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-0472-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 17, 2024
- FDA report date
- May 1, 2024
- Quantity
- 3,264 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0472-2024, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94440
- Address
- 750 Corporate Dr
- Code information
- Lot #: 17221312, Exp. 5/31/2024
- Postal code
- 07430-2009
- Report date
- May 1, 2024
- Product type
- Drugs
- Recall number
- D-0472-2024
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 3,264 bottles
- Reason for recall
- Failed Dissolution Specifications
- 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 USA.
- Recall initiation date
- Apr 17, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2024