FDA Drug recall D-0487-2023
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Moja…
- FDA Drug
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Moja… by Apollo Care, citing lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0487-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-08 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apollo Care |
| Distribution | MO |
Product
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
Reason
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Identifiers
| code_info | Lot #: AC-016581 |
|---|
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-0487-2023%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.