Reported Sep 4, 2013 · Terminated
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by:…
Actavis South Atlantic LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Actavis South Atlantic LLC · 13800 Nw 2nd St Ste 190 · Sunrise, FL · 33325-6243
Is this the product you have?
- buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only
- Distributed byActavis South Atlantic, LLC, Sunrise, FL 33325
- Packaged by
American Health PackagingColumbusOH 43217NDC 67767-142-30UPC 3 67767-142-30 6
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 CA2D14A, CA2D15A, Exp 12/13 2 CD2D07A, CD2D09A, CD2D10A, CD2D09B, CD2D08A, Exp 03/14 3 CE2D05A, CE2D06A, CE2D07A, CE2D11A, CE2D12A, CE2D10A, CE2D19A, Exp 04/14 4 CF2D01A, CF2D02A, CF2D03A, Exp 05/14 5 CG2D04A, CG2D05A, CG2D07A, CG2D09A, CG2D12A, CG2D12A, Exp 06/14 6 CH2D13A, CH2D14A, CH2D17A, CH2D18A, CH2D21A, Exp 07/14 7 CJ2D10A, CJ2D11A, Exp 08/14 - Amount recalled
- 428,268 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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