Ethanol for Injection 95% — Class II drug recall D-0986-2022
Terminated recall by US Specialty Formulations LLC, reported 2022-06-15, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0986-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | US Specialty Formulations LLC, Allentown, PA, United States |
| Recall initiated | 2022-05-24 |
| Classified | 2022-06-06 |
| Reported by FDA | 2022-06-15 |
| Terminated | 2024-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 781 vials |
| Reason classes | sterility |
| Lot numbers | 02RP1503A, 02RP1506A, 02RP1516A |
| Expiration dates | 2022-09-30, 2022-12-31, 2023-06-30 |
Product
Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229
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-0986-2022. 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.