Drug 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.
D-1142-2022
Product summary
- Firm
- A.P. Nonweiler
- Event
- Event 90298
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 833 gallons
- Official record key
drug-enforcement:D-1142-2022
Official wording
Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Code information: Lot: 54931, No Expiration date.
Distribution pattern: Distributed in States of WI and VA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations