Drug Enforcement D-0048-2025

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

Status

Completed

Classification

Class III

Report Date

November 27, 2024

Termination Date

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Product Information

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
Product quantity
10,872 jars
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Padagis US LLC
Address
3940 Quebec Ave N, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0048-2025
Event ID
95736
Recall initiation date
October 11, 2024
Center classification date
November 18, 2024
Code info
Lot #: 2024154238, 2024174344, Exp. Date 3/31/2026
More code info
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