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Recall Observatory FDA recall evidence

Drug product

Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR

D-104-2013

October 29, 2012

Class II

Product summary

Firm
Alara Pharmaceutical Co
Event
Event 63608
Status
Terminated
Classification
Class II
Quantity
7,432 bottles
Official record key
drug-enforcement:D-104-2013

Official wording

Reason: Subpotent; 15 month stability

Code information: 11T7011A, Exp. Date: 12/2012

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent

Field note

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