Why it was recalled
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Product description
Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote, Product Code 9999D361-250: (b) 1 U.S. gallon, Product Code 9999D361-001: A.P. Nonweiler Co., Inc., 3321 County Road A, Oshkosh, WI 54901.
Lot numbers, UPCs & expiration codes
Lot: 54931, No Expiration date.
Where it was sold
Distributed in States of WI and VA
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-1142-2022
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 11, 2022
- FDA report date
- Jun 22, 2022
- Quantity
- 833 gallons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- A.P. Nonweiler
Original FDA data
Every field from FDA enforcement report D-1142-2022, exactly as published.
Show all FDA fields
- City
- Oshkosh
- State
- WI
- Status
- Ongoing
- Country
- United States
- Event ID
- 90298
- Address
- 3321 County Road A
- Code information
- Lot: 54931, No Expiration date.
- Postal code
- 54901-1414
- Report date
- Jun 22, 2022
- Product type
- Drugs
- Recall number
- D-1142-2022
- Classification
- Class II
- Recalling firm
- A.P. Nonweiler
- Product quantity
- 833 gallons
- Reason for recall
- CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote, Product Code 9999D361-250: (b) 1 U.S. gallon, Product Code 9999D361-001: A.P. Nonweiler Co., Inc., 3321 County Road A, Oshkosh, WI 54901.
- Distribution pattern
- Distributed in States of WI and VA
- Recall initiation date
- May 11, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 10, 2022