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Recall Observatory FDA recall evidence

Drug product

Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, Iowa 51601

D-1394-2012

February 24, 2012

Class II

Product summary

Firm
Lloyd Inc
Event
Event 61252
Status
Terminated
Classification
Class II
Quantity
19,039 bottles
Official record key
drug-enforcement:D-1394-2012

Official wording

Reason: Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.

Code information: LOT NO.1092045

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent

Field note

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