buPROPion Hydrochloride Extended - Release Tablets recall: Failed Dissolution
buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
Why was buPROPion Hydrochloride Extended - Release Tablets recalled?
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
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 CB1D05A,
- Product
- buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
- Recalling firm
- Actavis Pharmaceuticals
- Quantity
- 14,856 bottles
- Distribution
- Nationwide
- Recall date
- March 6, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)