Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC ...
FDA Recall #D-107-2013 — Class II — December 4, 2012
Product Description
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.
Reason for Recall
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Recalling Firm
Abbott Laboratories — Abbott Park, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
28, 524 bottles
Distribution
US Nationwide and Puerto Rico
Code Information
LOT # 18262A8 Exp. 09/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated