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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Product Detail

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.
Recall Number D-107-2013
Classification Class II
Code Info LOT # 18262A8 Exp. 09/13
Product Distributed Qty 28, 524 bottles
Reason For Recall Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.

Event Detail

Event Id 63791
Product Type Drugs
Status Ongoing
Recalling Firm Abbott Laboratories
City Abbott Park
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide and Puerto Rico