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Drug FDA Class II Ongoing Contamination / non-sterility

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

PREQUEL SKIN Published Sep 18, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact PREQUEL SKIN or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Microbial contamination of non-sterile Products -

Hazards

Microbial contamination · primary

Affected products (1)

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

30,946 tubes

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

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 28, 2024
  2. Published
    Sep 18, 2024
Recall number
D-0657-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.