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 #114500Exipration Date 08/2013repackaging 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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