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Recall Observatory FDA recall evidence

Drug product

NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-331-01.

D-1300-2020

May 22, 2020

Class I

Product summary

Firm
Acella Pharmaceuticals, LLC
Event
Event 85721
Status
Terminated
Classification
Class I
Quantity
49,128 bottles
Official record key
drug-enforcement:D-1300-2020

Official wording

Reason: Superpotent Drug.

Code information: Lots: M331G18-1 Exp. JUN-2020, M331J18-1, M331J18-2, Exp. AUG-2020, M331M18-1, M331M18-2 Exp. NOV-2020

Distribution pattern: Distributed Nationwide in the US and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent