February 2011 FDA Recall Drug by Physicians Total Care, Inc.
D-317-2013 - Chemical Contamination

This Class III drug recall was voluntarily initiated by Physicians Total Care, Inc. on February 8, 2011 for the product Drug. The FDA reported the reason for recall as chemical contamination. The product was distributed in NC and the recall is currently terminated.

Recall Number: D-317-2013

Reason for Recall
Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).
Initiated
02-08-2011
Reported
05-15-2013
Quantity
60 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65004
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.
NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-01-2013
Product Description About Product Description
Full technical description of the product.
Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146.

Batch or Lot Expiration Information

Lot# 67JV Exp 08/13