Bupropion Hydrochloride Extended-Release Tablets recall: Failed Dissolution
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…
Why was Bupropion Hydrochloride Extended-Release Tablets recalled?
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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…
- Recalling firm
- Amerisource Health Services
- Quantity
- a) 15,409 bottles b) 5,128 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- November 23, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)