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Class III · Lower riskRecall completed

buPROPion Hydrochloride Extended-Release Tablets (XL)

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: CA2D14A, CA2D15A, Exp 12/13; CD2D07A, CD2D09A, CD2D10A, CD2D09B, CD2D08A, Exp 03/14; CE2D05A, CE2D06A, CE2D07A, CE2D11A, CE2D12A, CE2D10A, CE2D19A, Exp 04/14; CF2D01A, CF2D02A, CF2D03A, Exp 05/14; CG2D04A, CG2D05A, CG2D07A, CG2D09A, CG2D12A, CG2D12A, Exp 06/14; CH2D13A, CH2D14A, CH2D17A, CH2D18A, CH2D21A, Exp 07/14; CJ2D10A, CJ2D11A, Exp 08/14
Where it was soldNationwide and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forActavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217
NDC67767-142-30
Show the full FDA record
Full product labelbuPROPion 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 firmActavis South Atlantic LLC
DistributionNationwide and Puerto Rico
Quantity428,268 bottles
Recall initiated2013-08-21
Report date2013-09-04
Recall completed2014-04-10
Recall numberD-917-2013
ClassificationClass III
FDA statusTerminated
Origin on fileSunrise FL United States

Related

Bupropion recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.