Amerisource Health Services recalls buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila He
Recalled September 21, 2016 · FDA recall D-1501-2016 · Amerisource Health Services
Hazard
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing. · FDA Class III
Units
2626 bottles
Sold at
Nationwide and Puerto Rico
Description
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Product
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
Manufacturer(s)
Amerisource Health Services
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →