buPROPion Hydrochloride Extended Release Tablets recall: Failed Dissolution
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
Why was buPROPion Hydrochloride Extended Release Tablets recalled?
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
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?
The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
- Product
- buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
- Recalling firm
- American Health Packaging
- Quantity
- 389 cartons
- Distribution
- Nationwide
- Recall date
- August 21, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)