FDA Drug recall D-0986-2022
Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69…
- FDA Drug
- Class II
- terminated
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69… by Us Specialty Formulations, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0986-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-24 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Us Specialty Formulations |
| Distribution | US |
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
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: 02RP1503A, exp. date 30-Sep-22; 02RP1506A, exp. date 31-Dec-22; 02RP1516A, exp. date 30-Jun-23 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0986-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.