Reported Mar 6, 2013 · Terminated

buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis…

Actavis Pharmaceuticals

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: Actavis Pharmaceuticals · 60 Columbia Rd Bldg B · Morristown, NJ · 07960-4535

Is this the product you have?

  • buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only
  • NDC 67767-142-30 Actavis Distributed byActavis South Atlantic LLC Sunrise
  • FL 33325 Packaged by byAmerica Health Packaging Columbus, OH 43217
Lot codes and dates
  • Lot CB1D05A,
Amount recalled
14,856 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.

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 Jan 13, 2014 · Data as of Sep 19, 6:32 PM UTC

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