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 5

FDA recall notice · announced June 22, 2022 · A.p. Nonweiler

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Notes

Distribution: Distributed in States of WI and VA
Lot/code information: Lot: 54931, No Expiration date.
Quantity: 833 gallons
Status: Ongoing
Products in this recall event:
- 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. (D-1142-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.