FDA Drug recall D-0646-2023
FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 380…
- FDA Drug
- Class II
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 380… by Apollo Care, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0646-2023 |
| 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 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: AC-016644, Exp. Date 05/08/2023; AC-016659, Exp. Date 09/26/2023 |
|---|
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-0646-2023%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.