Drug product
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.
D-0017-2023
Product summary
- Event
- Event 90973
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5-10 gallons
- Official record key
drug-enforcement:D-0017-2023
Official wording
Reason: Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Code information: Batch 20117206. No Expiration dates Product Code: a) 3030-8 (8 oz) b) 3030-3 (32 oz) c) 3030-5 (1.7 fl oz./50 mL)
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination
-
Manufacturing or process control
CGMP Deviations