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Recall Observatory FDA recall evidence

Drug product

Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90.

D-1694-2012

July 19, 2012

Class II

Product summary

Firm
Abbott Laboratories
Event
Event 62674
Status
Terminated
Classification
Class II
Quantity
53,448 Bottles
Official record key
drug-enforcement:D-1694-2012

Official wording

Reason: Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.

Code information: 18265A8, Exp 09/20/2013

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.