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Recall Observatory FDA recall evidence

Drug product

NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-329-01.

D-1298-2020

May 22, 2020

Class I

Product summary

Firm
Acella Pharmaceuticals, LLC
Event
Event 85721
Status
Terminated
Classification
Class I
Quantity
112,140 bottles
Official record key
drug-enforcement:D-1298-2020

Official wording

Reason: Superpotent Drug.

Code information: Lots: M329H18-1, Exp. JUL-2020; M329J18-1, M329J18-2, M329J18-3 Exp. AUG-2020; M329M18-2 Exp. NOV-2020, M329A19-1 Exp. DEC-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