D-499-2013 Class III Terminated
FDA drug recall D-499-2013 was initiated by Physicians Total Care, Inc. on March 18, 2013 and is designated Class III. Reason for recall: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing The recall status is terminated (terminated August 15, 2013). Affected quantity: 6 cards of 28 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- June 5, 2013
- Initiation Date
- March 18, 2013
- Termination Date
- August 15, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 cards of 28 tablets
Product Description
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
Reason for Recall
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Distribution Pattern
MO
Code Information
Physicians Total Care Lots: 6Z4C Exp. 10/31/2013