Amerisource Health Services recalls buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila H…
- Recall date
- August 4, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1501-2016
- FDA classification
- Class III
- Brand / firm
- Amerisource Health Services
- Sold / distributed
- Nationwide and Puerto Rico
Why it was recalled
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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