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
- Center classification date
- Sep 9, 2024