FDA recall D-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

Reason for recall

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

Distribution

nationwide in the U.S.

Key facts

Status

Ongoing

Initiation date

2023-08-14

Report date

2023-08-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

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