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
Product summary
- 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
Failed Impurity/Degradation Specification