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Recall Observatory FDA recall evidence

Drug product

NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

D-0395-2021

April 29, 2021

Class I

Product summary

Firm
Acella Pharmaceuticals, LLC
Event
Event 87843
Status
Terminated
Classification
Class I
Quantity
a) 66,155 bottles; b) 26,212 bottles
Official record key
drug-enforcement:D-0395-2021

Official wording

Reason: Subpotent Drug

Code information: Lots: a) M327D20-1, M327D20-3 Exp. 03/31/2022, M327H19-3A Exp. 07/31/2021, M327L19-1 Exp. 04/30/2021; b) M327D20-1 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