REGULATORY INTELLIGENCE·Recall
Padagis US LLC Initiates Class III Recall of Triamcinolone Acetonide Cream Due to Potency Deviations
Padagis US LLC has completed a Class III recall (D-0048-2025) of 10,872 jars of Triamcinolone Acetonide Cream USP, 0.025%, due to subpotent and superpotent drug findings. This voluntary action, initiated October 11, 2024, stemmed from out-of-specification stability test results at their Minneapolis, MN facility. Procurement and regulatory teams must scrutinize supplier quality systems, particularly for long-term stability and container uniformity, to mitigate supply chain risks.
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