August 2024 FDA Recall Drug by Prequel Skin
D-0657-2024 - Microbial contamination of non-sterile Products -

This Class II drug recall was voluntarily initiated by Prequel Skin on August 28, 2024 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products -. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0657-2024

Reason for Recall
Microbial contamination of non-sterile Products -
Initiated
08-28-2024
Reported
09-18-2024
Quantity
30,946 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95250
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
PREQUEL SKIN
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed nationwide in USA and on line
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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