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Recall Observatory FDA recall evidence

Drug product

Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05

D-0048-2025

October 11, 2024

Class III

Product summary

Firm
Padagis US LLC
Event
Event 95736
Status
Terminated
Classification
Class III
Quantity
10,872 jars
Official record key
drug-enforcement:D-0048-2025

Official wording

Reason: Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

Code information: Lot #: 2024154238, 2024174344, Exp. Date 3/31/2026

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent