Reported Aug 14, 2013 · Terminated

BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by:…

Actavis Inc.

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 Inc · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120

Is this the product you have?

  • BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only
  • Distributed byActavis South Atlantic, LLC, Sunrise, FL 33325
  • Packaged by
    • American Health Packaging
    • Columbus
    • OH 43217
    • NDC 67767-142-30
    • UPC 3 67767-142-30 6
Lot codes and dates
    • Lot #: CG2D18A
    • Exp 06/14
Amount recalled
15,132 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.

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 May 9, 2014 · Data as of Sep 19, 7:01 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.