BuPROPion Hydrochloride Extended-Release Tablets recall: Failed Dissolution
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
Why was BuPROPion Hydrochloride Extended-Release Tablets recalled?
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
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 #: CG2D18A, Exp 06/14
- Product
- BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
- Recalling firm
- Actavis Inc
- Quantity
- 15,132 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- August 14, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)