Recalls / Class III
Class IIID-499-2013
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
- Affected lot / code info
- Physicians Total Care Lots: 6Z4C Exp. 10/31/2013
Why it was recalled
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Recalling firm
- Firm
- Physicians Total Care, Inc.
- Notification channel
- FAX
- Type
- Voluntary: Firm initiated
- Address
- 12515 E 55th St Ste 100, N/A, Tulsa, Oklahoma 74146-6234
Distribution
- Quantity
- 6 cards of 28 tablets
- Distribution pattern
- MO
Timeline
- Recall initiated
- 2013-03-18
- FDA classified
- 2013-05-30
- Posted by FDA
- 2013-06-05
- Terminated
- 2013-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-499-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.