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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