June 2024 FDA Recall Drug by Brands International Corporation
D-0598-2024 - Microbial Contamination of Non-Sterile Products

This Class II drug recall was voluntarily initiated by Brands International Corporation on June 10, 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-0598-2024

Reason for Recall
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Initiated
06-10-2024
Reported
07-24-2024
Quantity
120,319 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94898
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.
Brands International Corporation
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, L3X 2S2, Made in Canada.

Batch or Lot Expiration Information

Lot# 24092009, Exp 03/27; 24094010, Exp 04/27