Class III
Terminated
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
- Company
- Amerisource Health Services
- Recall Initiated
- August 4, 2016
- Posted
- September 21, 2016
- Recall Number
- D-1501-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2626 bottles
- Firm Location
- Columbus, OH, United States
Reason for Recall
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: MS1509, Exp 12/17
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