February 2012 FDA Recall Drug by Physicians Total Care, Inc.
D-1389-2012 - Chemical Contamination

This Class II drug recall was voluntarily initiated by Physicians Total Care, Inc. on February 8, 2012 for the product Drug. The FDA reported the reason for recall as chemical contamination. The product was distributed in AK, NC, GA and the recall is currently terminated.

Recall Number: D-1389-2012

Reason for Recall
Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.
Initiated
02-08-2012
Reported
06-27-2012
Quantity
3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62239
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
AK, NC, GA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-05-2012
Product Description About Product Description
Full technical description of the product.
Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0

Batch or Lot Expiration Information

Lot# Lots 6284, 60DI, 61AA.