D-1095-2023 Class III Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 30, 2023
- Initiation Date
- August 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,200 bottles
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
Reason for Recall
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Distribution Pattern
nationwide in the U.S.
Code Information
Batch # 19224744