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

FDA Recall #D-0657-2024 — Class II — August 28, 2024

Recall #D-0657-2024 Date: August 28, 2024 Classification: Class II Status: Ongoing

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

Reason for Recall

Microbial contamination of non-sterile Products -

Recalling Firm

PREQUEL SKIN — W Hollywood, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

30,946 tubes

Distribution

Distributed nationwide in USA and on line

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated