Why it was recalled
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Product description
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
Lot numbers, UPCs & expiration codes
Batch # 19224744
Where it was sold
nationwide in the U.S.
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-1095-2023
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Aug 14, 2023
- FDA report date
- Aug 30, 2023
- Quantity
- 1,200 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-1095-2023, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 92859
- Address
- 750 Corporate Dr
- Code information
- Batch # 19224744
- Postal code
- 07430-2009
- Report date
- Aug 30, 2023
- Product type
- Drugs
- Recall number
- D-1095-2023
- Classification
- Class III
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 1,200 bottles
- Reason for recall
- Subpotent: Out of Specification for Assay Test at the 3-month time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
- Distribution pattern
- nationwide in the U.S.
- Recall initiation date
- Aug 14, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 22, 2023