FDA Recall D-1095-2023

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class III Ongoing 1004 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Batch # 19224744

Quantity: 1,200 bottles

Reason for recall

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

Recall record

Recall number: D-1095-2023
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: nationwide in the U.S.
Recall initiated: 2023-08-14
Classified by FDA Center: 2023-08-22
FDA published: 2023-08-30
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
Generic name(s): TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-294, 68462-329, 68462-295, 68462-296
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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