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.
Reported: June 22, 2022 Initiated: May 11, 2022 #D-1142-2022
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.
Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Details
- Recalling Firm
- A.P. Nonweiler
- Units Affected
- 833 gallons
- Distribution
- Distributed in States of WI and VA
- Location
- Oshkosh, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by A.P. Nonweiler. Units affected: 833 gallons.
Why was this product recalled? ▼
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 22, 2022. Severity: Moderate. Recall number: D-1142-2022.
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