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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-0398-2021

April 29, 2021

Class I

Product summary

Firm
Acella Pharmaceuticals, LLC
Event
Event 87843
Status
Terminated
Classification
Class I
Quantity
79,344 bottles
Official record key
drug-enforcement:D-0398-2021

Official wording

Reason: Subpotent Drug

Code information: Lots: M331J19-10A, M331J19-11, M331J19-2A, M331J19-6A, Exp. 08/31/2021, M331K19-1, M331K19-2, M331K19-6, Exp. 09/30/2021

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