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Recall Observatory FDA recall evidence

Drug product

Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg], packaged in a) 30-count bottles (NDC 64727-3305-4), b) 60-count bottles (NDC 64727-3305-5), c) 90-count bottles (NDC 64727-3305-6), and 100-count bottles (NDC 64727-3305-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3305-1

D-1619-2020

August 25, 2020

Class I

Product summary

Firm
RLC Labs Inc.
Event
Event 86343
Status
Terminated
Classification
Class I
Quantity
N/A
Official record key
drug-enforcement:D-1619-2020

Official wording

Reason: Subpotent Drug: FDA analysis found product to be subpotent

Code information: Lot #: 109286, Exp. Date 10/2022

Distribution pattern: Nationwide in the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent