FDA-Drug2023-03-15Class II

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.

Amerisource Health Services LLC
Hazard

Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.

Sold states
Nationwide in the USA
Affected count
422 cartons
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
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.

Official notice

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

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