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Recall Observatory FDA recall evidence

Drug product

BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4

D-0657-2024

August 28, 2024

Class II

Product summary

Firm
PREQUEL SKIN
Event
Event 95250
Status
Ongoing
Classification
Class II
Quantity
30,946 tubes
Official record key
drug-enforcement:D-0657-2024

Official wording

Reason: Microbial contamination of non-sterile Products -

Code information: Lot: X4054A, Exp: 2/2026; X4136A, X4137A, X4138A, Exp: 5/2026

Distribution pattern: Distributed nationwide in USA and on line

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination