Why it was recalled
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Product description
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, 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.
Lot numbers, UPCs & expiration codes
Batch: 20087131. No Expiration dates Product Code: a) 3020-8 (8 oz) b) 3020-3 (32 oz) c) 3020-5 (1.7 fl oz./50 mL)
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0016-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 15, 2022
- FDA report date
- Nov 2, 2022
- Quantity
- 5-10 gallons
- Recall type
- N/A
- Recalling firm
- Ultra Chem Labs Corp
Original FDA data
Every field from FDA enforcement report D-0016-2023, exactly as published.
Show all FDA fields
- City
- Ontario
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 90973
- Address
- 4581 Brickell Privado St
- Code information
- Batch: 20087131. No Expiration dates Product Code: a) 3020-8 (8 oz) b) 3020-3 (32 oz) c) 3020-5 (1.7 fl oz./50 mL)
- Postal code
- 91761-7828
- Report date
- Nov 2, 2022
- Product type
- Drugs
- Recall number
- D-0016-2023
- Classification
- Class II
- Recalling firm
- Ultra Chem Labs Corp
- Product quantity
- 5-10 gallons
- Termination date
- Aug 13, 2024
- Reason for recall
- Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
- Product description
- Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 15, 2022
- Initial firm notification
- Center classification date
- Oct 21, 2022