December 2012 FDA Recall Synthroid by Abbott Laboratories
D-107-2013 - Labeling
This Class II drug recall was voluntarily initiated by Abbott Laboratories on December 4, 2012 for the product Synthroid. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-107-2013
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
12-04-2012
01-09-2013
28, 524 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Abbott Laboratories
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide and Puerto Rico
07-10-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.
Batch or Lot Expiration Information
Lot# 18262A8 Exp. 09/13
