May 2022 FDA Recall Drug by A.p. Nonweiler
D-1142-2022 - CGMP Deviations
This Class II drug recall was voluntarily initiated by A.p. Nonweiler on May 11, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed in States of WI and VA and the recall is currently ongoing.
Recall Number: D-1142-2022
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
05-11-2022
06-22-2022
833 gallons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
A.P. Nonweiler
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed in States of WI and VA
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# Lot: 54931, No Expiration date.
