Drug 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.
D-0598-2024
Product summary
- Event
- Event 94898
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 120,319 bottles
- Official record key
drug-enforcement:D-0598-2024
Official wording
Reason: Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Code information: Lot# 24092009, Exp 03/27; 24094010, Exp 04/27
Distribution pattern: USA nationwide.
Derived failure modes
-
Microbial contamination
Microbial Contamination