PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: March 15, 2023 Initiated: January 27, 2023 #D-0436-2023

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.

Details

Units Affected
422 cartons
Distribution
Nationwide in the USA
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
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.. Recalled by Amerisource Health Services LLC. Units affected: 422 cartons.
Why was this product recalled?
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 15, 2023. Severity: Moderate. Recall number: D-0436-2023.