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Recall Observatory FDA recall evidence

Drug 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.

D-107-2013

December 04, 2012

Class II

Product summary

Firm
Abbott Laboratories
Event
Event 63791
Status
Terminated
Classification
Class II
Quantity
28, 524 bottles
Official record key
drug-enforcement:D-107-2013

Official wording

Reason: Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.

Code information: LOT # 18262A8 Exp. 09/13

Distribution pattern: US Nationwide and Puerto Rico

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Error