Drug Enforcement D-0657-2024

Microbial contamination of non-sterile Products -

Status

Ongoing

Classification

Class II

Report Date

September 18, 2024

Termination Date

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Product Information

Product description
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
Product quantity
30,946 tubes
Reason for recall
Microbial contamination of non-sterile Products -
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Distributed nationwide in USA and on line

Location & Firm

Recalling firm
PREQUEL SKIN
Address
8560 W Sunset Blvd Ste 800

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0657-2024
Event ID
95250
Recall initiation date
August 28, 2024
Center classification date
September 9, 2024
Code info
Lot: X4054A, Exp: 2/2026; X4136A, X4137A, X4138A, Exp: 5/2026
More code info
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