Recall record at a glance
| Official record | D-1142-2022 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | A.P. Nonweiler |
| Report date | Jun 22, 2022 |
| Recall initiation date | May 11, 2022 |
| Quantity | 833 gallons |
| Location | Oshkosh, WI, United States |
Official 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.
Why the product was recalled
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Distribution information
Distributed in States of WI and VA
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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