Amerisource Health Services recalls Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-coun
Recalled November 23, 2016 · FDA recall D-0137-2017 · Amerisource Health Services
Hazard
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples. · FDA Class III
Units
a) 15,409 bottles b) 5,128 bottles
Sold at
Nationwide and Puerto Rico
Description
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Product
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
Manufacturer(s)
Amerisource Health Services
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →