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Recall Observatory FDA recall evidence

Drug product

NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count bottles (NDC 42192-329-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

D-0396-2021

April 29, 2021

Class I

Product summary

Firm
Acella Pharmaceuticals, LLC
Event
Event 87843
Status
Terminated
Classification
Class I
Quantity
a) 113,019 bottles; b) 44,900 bottles
Official record key
drug-enforcement:D-0396-2021

Official wording

Reason: Subpotent Drug

Code information: Lots: a) M329D20-1, M329D20-2, M329D20-3 Exp. 03/31/2022, ; b) M329D20-2 Exp. 03/31/2022

Distribution pattern: Nationwide within the United States including Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent