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Recall Observatory FDA recall evidence

Drug product

Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA

D-499-2013

March 18, 2013

Class III

Product summary

Firm
Physicians Total Care, Inc.
Event
Event 64996
Status
Terminated
Classification
Class III
Quantity
6 cards of 28 tablets
Official record key
drug-enforcement:D-499-2013

Official wording

Reason: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Code information: Physicians Total Care Lots: 6Z4C Exp. 10/31/2013

Distribution pattern: MO

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurity/Degradation Specification