Class III
Terminated
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
This recall has been terminated (originally issued November 23, 2016).
- Company
- Amerisource Health Services
- Recall Initiated
- October 27, 2016
- Posted
- November 23, 2016
- Recall Number
- D-0137-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 15,409 bottles b) 5,128 bottles
- Firm Location
- Columbus, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: a) M601509, Exp 3/31/2018; M606506, Exp 4/30/2018; b) M601510, Exp 3/31/2018; M604444, Exp 4/30/2018; M606515, Exp 4/30/2018.
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