Why it was recalled
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
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
Lot numbers, UPCs & expiration codes
Physicians Total Care Lots: 6Z4C Exp. 10/31/2013
Where it was sold
MO
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-499-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 18, 2013
- FDA report date
- Jun 5, 2013
- Quantity
- 6 cards of 28 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Physicians Total Care, Inc.
Original FDA data
Every field from FDA enforcement report D-499-2013, exactly as published.
Show all FDA fields
- City
- Tulsa
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 64996
- Address
- 12515 E 55th St Ste 100
- Code information
- Physicians Total Care Lots: 6Z4C Exp. 10/31/2013
- Postal code
- 74146-6234
- Report date
- Jun 5, 2013
- Product type
- Drugs
- Recall number
- D-499-2013
- Classification
- Class III
- Recalling firm
- Physicians Total Care, Inc.
- Product quantity
- 6 cards of 28 tablets
- Termination date
- Aug 15, 2013
- Reason for recall
- Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- MO
- Recall initiation date
- Mar 18, 2013
- Initial firm notification
- FAX
- Center classification date
- May 30, 2013