FDA-Drug2016-09-21Class III
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
Amerisource Health Services
Hazard
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Sold states
Nationwide and Puerto Rico
Affected count
2626 bottles
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1501-2016Don't want to check this manually?
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