Recalls / Class III
Class IIID-1501-2016
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
- Affected lot / code info
- Lot #: MS1509, Exp 12/17
Why it was recalled
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Recalling firm
- Firm
- Amerisource Health Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 2626 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-08-04
- FDA classified
- 2016-09-15
- Posted by FDA
- 2016-09-21
- Terminated
- 2017-07-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1501-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.