Drug recall
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon…
FDA recall event 91272 · Class II · NCH Life Sciences LLC
Key facts
| Event ID | 91272 |
|---|---|
| Recall numbers | D-0092-2023 |
| Recalling firm | NCH Life Sciences LLC |
| Product type | Drugs |
| Products | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03… |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits. |
| Initiation date | Dec 9, 2022 |
| Report date | Jan 4, 2023 |
| City | Irving |
| State | TX |
| Country | United States |
| FEI number | 1610021 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: