buPROPion Hydrochloride Extended-Release Tablets recall: Failed Dissolution
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad…
Why was buPROPion Hydrochloride Extended-Release Tablets recalled?
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
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 #: MS1509, Exp 12/17
- Product
- buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad…
- Recalling firm
- Amerisource Health Services
- Quantity
- 2626 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- September 21, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)