Recall: D-1095-2023

Class III - Minor Violations

Class IIIClassification

2023-08-14Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

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

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

Distribution

nationwide in the U.S.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.