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 PackagingColumbusOH 43217NDC 67767-142-30UPC 3 67767-142-30 6
- Lot codes and dates
Lot #: CG2D18AExp 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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