Accutome Rx Accu-WASH — Class II drug recall D-0458-2020
Completed recall by Altaire Pharmaceuticals, Inc., reported 2019-11-27, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0458-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Altaire Pharmaceuticals, Inc., Aquebogue, NY, United States |
| Recall initiated | 2019-07-02 |
| Classified | 2019-11-15 |
| Reported by FDA | 2019-11-27 |
| Distributed | Nationwide (US) |
| Quantity | 90,072 units |
| Reason classes | sterility |
| NDC | 63448-0411-04 |
Product
Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04
Reason for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0458-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.