Drug recall D-1095-2023

Class III Ongoing reported Aug 30, 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

Reason for recall

Subpotent: Out of Specification for Assay Test at the 3-month time point.

Lots and codes

Batch # 19224744

Recall details

Recalling firm
Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Quantity
1,200 bottles
Distribution
nationwide in the U.S.
Type
Voluntary: Firm initiated
Recall initiated
August 14, 2023

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