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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 #: CG2D18A, Exp 06/14
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: Dissolution test results at 8 hour time-point were above approved specification limits.

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 Inc
DistributionNationwide and Puerto Rico
Quantity15,132 bottles
Recall initiated2013-07-31
Report date2013-08-14
Recall completed2014-05-09
Recall numberD-855-2013
ClassificationClass III
FDA statusTerminated
Origin on fileParsippany NJ United States

Related

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.