← FDA ENFORCEMENT
D-0048-2025Class III

Padagis US LLC

Recalling firm
Padagis US LLC
Product type
Drug
Status
Terminated
Report date
2024-11-27
Distribution
Nationwide in the USA
Firm state
MN
Product quantity
10,872 jars
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.