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Recall Observatory FDA recall evidence

Drug product

Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01

D-0403-2015

February 26, 2015

Class III

Product summary

Firm
Pfizer Inc.
Event
Event 70614
Status
Terminated
Classification
Class III
Quantity
137 bottles
Official record key
drug-enforcement:D-0403-2015

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot 13T02, Exp. 12/15

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications