FDA Drug recall D-0634-2023
FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202
- FDA Drug
- Class II
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202 by Apollo Care, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0634-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-02 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apollo Care |
| Distribution | MO |
Product
FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: AC-016624, Exp. Date 06/10/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0634-2023%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.