Status
Terminated
Drug Enforcement D-499-2013
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Classification
Class III
Report Date
June 5, 2013
Termination Date
August 15, 2013
Product Information
- 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
- Product quantity
- 6 cards of 28 tablets
- Reason for recall
- Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- Recall initiation reason
- —
- Initial firm notification
- FAX
- Distribution pattern
- MO
Location & Firm
- Recalling firm
- Physicians Total Care, Inc.
- Address
-
12515 E 55th St Ste 100, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-499-2013
- Event ID
- 64996
- Recall initiation date
- March 18, 2013
- Center classification date
- May 30, 2013
- Code info
- Physicians Total Care Lots: 6Z4C Exp. 10/31/2013
- More code info
- —