FDA Drug Recalls

Recalls / Class III

Class IIID-0404-2015

Product

Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01

Affected lot / code info
Lot 13T03, Exp 12/15

Why it was recalled

Failed Impurities/Degradation Specifications

Recalling firm

Firm
Pfizer Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
235 East 42nd Street, N/A, New York, New York 10017-5703

Distribution

Quantity
139 bottles
Distribution pattern
Nationwide

Timeline

Recall initiated
2015-02-26
FDA classified
2015-03-05
Posted by FDA
2015-03-11
Terminated
2017-07-29
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0404-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.