Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (1...
FDA Recall #D-0436-2023 — Class II — January 27, 2023
Product Description
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
Reason for Recall
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Recalling Firm
Amerisource Health Services LLC — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
422 cartons
Distribution
Nationwide in the USA
Code Information
Lot 1009065, Exp 12/31/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated