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.
FDA recall notice · announced March 15, 2023 · Amerisource Health Services
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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.
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot 1009065, Exp 12/31/2023
Quantity: 422 cartons
Status: Terminated
Products in this recall event:
- 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 (D-0436-2023)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.