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Recall Observatory FDA recall evidence

Drug product

Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

D-1393-2012

February 03, 2012

Class II

Product summary

Firm
Lloyd Inc
Event
Event 61094
Status
Terminated
Classification
Class II
Quantity
19,166 bottles
Official record key
drug-enforcement:D-1393-2012

Official wording

Reason: Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.

Code information: Lot 1087589

Distribution pattern: Nationwide and PR.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent