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Class III · Lower riskRecall completed

buPROPion Hydrochloride Extended Release Tablets

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

Does this affect you?
Check your lot numberThe following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
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 Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.

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 / forAmerican Health Packaging, Columbus, OH ---
NDC68084-470-01
Show the full FDA record
Full product labelbuPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
Recalling firmAmerican Health Packaging
DistributionNationwide
Quantity389 cartons
Recall initiated2013-02-04
Report date2013-08-21
Recall completed2013-08-28
Recall numberD-892-2013
ClassificationClass III
FDA statusTerminated
Origin on fileColumbus OH United States

Related

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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.