March 2013 FDA Recall Drug by Physicians Total Care, Inc. (D-499-2013 - Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing)

This Class III drug recall was voluntarily initiated by Physicians Total Care, Inc. on March 18, 2013 for the product Drug. The FDA reported the reason for recall as failed impurity/degradation specification; an impurity identified as n-butyl-benzene sulfonamide (nbbs) was detected during impurity testing. The product was distributed in MO and the recall is currently terminated.

Recall Number: D-499-2013

Reason for Recall
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Initiated
03-18-2013
Reported
06-05-2013
Quantity
6 cards of 28 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64996
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Physicians Total Care, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MO
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2013
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Physicians Total Care Lots: 6Z4C Exp. 10/31/2013