FDA recall D-0536-2023

Product

Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-504-01; NDC Unit Dose: 60687-504-11, barcode (01) 003 60687 504 11 7.

Reason for recall

Failed Dissolution Specifications: Out of specification dissolution results above specified values.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-03-16

Report date

2023-04-26

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-0536-2023