Reported Apr 24, 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 by
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Actavis South Atlantic LLC, Sunrise, FL 33325 |
| 2 | Packaged by: American Health Packaging, Columbus, OH 43217 |
| 3 | NDC 67767-142-30. |
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 CC1D11A, CC1D12A, CC1D17A, CC1D18A, CD1D05A, CD1D07A, CD1D08A, CD1D14A, CD1D15A, CD1D16A, CE1D08A, Exp 03/13 2 CE1D03A, CE1D04A, CE1D07A, CE1D06A, CE1D05A, CE1D13A, CE1D14A, CE1D15A, Exp 04/13 3 CF1D01A, CE1D24A, CF1D02A, Exp 05/13 4 CH1D08A, CH1D09A, Exp 07/13 5 CJ1D01A, CH1D11A, CH1D10A, CJ1D09A, CJ1D02A, CJ1D10A Exp 08/13 6 CL1D05A, CL1D06A, CK1D05B, CK1D06A, Exp 10/13 7 CL1D08A, CM1D01A, CM1D02A, Exp 11/13 - Amount recalled
- 555,672 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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