Recalls / Class III
Class IIID-1095-2023
Product
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
- Brand name
- Trandolapril And Verapamil Hydrochloride
- Generic name
- Trandolapril And Verapamil Hydrochloride
- Active ingredients
- Trandolapril, Verapamil Hydrochloride
- Route
- Oral
- NDCs
- 68462-294, 68462-329, 68462-295, 68462-296
- FDA application
- ANDA079135
- Affected lot / code info
- Batch # 19224744
Why it was recalled
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 1,200 bottles
- Distribution pattern
- nationwide in the U.S.
Timeline
- Recall initiated
- 2023-08-14
- FDA classified
- 2023-08-22
- Posted by FDA
- 2023-08-30
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1095-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.