November 2012 FDA Recall Drug by Physicians Total Care, Inc. (D-214-2013 - Subpotent; 15 month stability (by mfr))

This Class II drug recall was voluntarily initiated by Physicians Total Care, Inc. on November 15, 2012 for the product Drug. The FDA reported the reason for recall as subpotent; 15 month stability (by mfr). The product was distributed in OH, GA and the recall is currently terminated.

Recall Number: D-214-2013

Reason for Recall
Subpotent; 15 month stability (by mfr)
Initiated
11-15-2012
Reported
03-27-2013
Quantity
90 pills

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63846
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.
OH, GA
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.
Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx, Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK --- NDC 54868-4507-00

Batch or Lot Expiration Information

Lot# 6WX2 exp 12/31/2012