October 2012 FDA Recall Drug by Alara Pharmaceutical Co
D-104-2013 - Subpotent; 15 month stability

This Class II drug recall was voluntarily initiated by Alara Pharmaceutical Co on October 29, 2012 for the product Drug. The FDA reported the reason for recall as subpotent; 15 month stability. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-104-2013

Reason for Recall
Subpotent; 15 month stability
Initiated
10-29-2012
Reported
01-02-2013
Quantity
7,432 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63608
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.
Alara Pharmaceutical Co
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-03-2014
Product Description About Product Description
Full technical description of the product.
Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR

Batch or Lot Expiration Information

Lot# 11T7011A, Exp. Date: 12/2012