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Class III · Lower riskRecall completed

buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg

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

Does this affect you?
Check your lot numberLot CB1D05A,
Where it was soldNationwide
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; 8-hours for the 18-month stability testing point.

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 by: America Health Packaging Columbus, OH 43217
NDC67767-142-30
Show the full FDA record
Full product labelbuPROPion 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 firmActavis Pharmaceuticals
DistributionNationwide
Quantity14,856 bottles
Recall initiated2013-01-04
Report date2013-03-06
Recall completed2014-01-13
Recall numberD-175-2013
ClassificationClass III
FDA statusTerminated
Origin on fileMorristown 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.