FDA-Drug2023-08-30Class III

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

Glenmark Pharmaceuticals Inc., USA
Hazard

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

Sold states
nationwide in the U.S.
Affected count
1,200 bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1095-2023

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