Drug product
Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005320, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
D-1305-2014
Product summary
- Firm
- Mangiacotti
- Event
- Event 68136
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1305-2014
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Code information: Lot Code: 13350
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination