Recalling firm
Glenmark Pharmaceuticals Inc., USA
Product type
Drug
Status
Ongoing
Report date
2023-08-30
Distribution
nationwide in the U.S.
Firm state
NJ
Product quantity
1,200 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Product description
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
Code / lot info
Batch # 19224744
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.