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Class II: temporary or reversible health riskOngoing

Prequel Skin Barrier Therapy Skin Protectant Cream Recall

BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Di…

PREQUEL SKIN · W Hollywood, CA

Risk level
Class II
Reported by FDA
Sep 18, 2024
Recall ID
D-0657-2024
Check your lot numberHow we source this data

Summary

Prequel Skin recalled Barrier Therapy Skin Protectant Cream starting Aug 28, 2024. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0657-2024 on Sep 18, 2024. Reason: Microbial contamination of non-sterile Products -. Status: Ongoing.

Why it was recalled

Microbial contamination of non-sterile Products -

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Distributed nationwide in USA and on line

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0657-2024
Classification
Class II
Status
Ongoing
Recall initiated
Aug 28, 2024
FDA report date
Sep 18, 2024
Quantity
30,946 tubes
Recall type
Voluntary: Firm initiated
Recalling firm
PREQUEL SKIN

Original FDA data

Every field from FDA enforcement report D-0657-2024, exactly as published.

Show all FDA fields
City
W Hollywood
State
CA
Status
Ongoing
Country
United States
Event ID
95250
Address
8560 W Sunset Blvd Ste 800
Code information
Lot: X4054A, Exp: 2/2026; X4136A, X4137A, X4138A, Exp: 5/2026
Postal code
90069-2340
Report date
Sep 18, 2024
Product type
Drugs
Recall number
D-0657-2024
Classification
Class II
Recalling firm
PREQUEL SKIN
Product quantity
30,946 tubes
Reason for recall
Microbial contamination of non-sterile Products -
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Distributed nationwide in USA and on line
Recall initiation date
Aug 28, 2024
Initial firm notification
E-Mail
Center classification date
Sep 9, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0657-2024, published Sep 18, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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