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Recall Observatory FDA recall evidence

Drug product

S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.

D-0446-2024

March 01, 2024

Class II

Product summary

Firm
Specialty Process Labs LLC
Event
Event 94268
Status
Completed
Classification
Class II
Quantity
26 units
Official record key
drug-enforcement:D-0446-2024

Official wording

Reason: Failed Stability Specifications

Code information: Lot #: H22212-FSV, Exp: 11/21/2024 1.0 kg pack size.

Distribution pattern: U.S. Nationwide.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Stability Specifications