FDA recall D-0436-2023

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-01-27

Report date

2023-03-15

Termination date

2024-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0436-2023