FentaNYL 500 mcg — Class II drug recall D-0646-2023
Ongoing recall by Apollo Care, LLC, reported 2023-05-24, distributed in MO. Lack of Assurance of Sterility
| Recall number | D-0646-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apollo Care, LLC, Columbia, MO, United States |
| Recall initiated | 2023-05-02 |
| Classified | 2023-05-18 |
| Reported by FDA | 2023-05-24 |
| Distributed | MO |
| Quantity | 308 bags |
| Reason classes | sterility |
| NDC | 71170-0950-25 |
| Lot numbers | AC-016644, AC-016659 |
| Expiration dates | 2023-05-08, 2023-09-26 |
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 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-0646-2023. 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.