Reported Aug 21, 2013 · Terminated

buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually…

American Health Packaging

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: American Health Packaging · 2550 John Glenn Ave · Columbus, OH · 43217-1188

Is this the product you have?

  • buPROPion 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 byAmerican Health Packaging, Columbus, OH --- NDC 68084-470-01
Lot codes and dates
  • The following
  • codes are affects by the recall
    • Lot #114500
    • Exipration Date 08/2013
    • repackaging date 12/04/2011
Amount recalled
389 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 28, 2013 · Data as of Sep 19, 6:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.