fentaNYL Citrate 50 mcg per mL — Class II drug recall D-1089-2020
Terminated recall by PharMEDium Services, LLC, reported 2020-04-15, distributed nationwide. Firm is recalling 46 lots of various products because of a lack of sterility assurance.
| Recall number | D-1089-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PharMEDium Services, LLC, Dayton, NJ, United States |
| Recall initiated | 2020-03-16 |
| Classified | 2020-04-06 |
| Reported by FDA | 2020-04-15 |
| Terminated | 2025-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 290 units |
| Reason classes | sterility |
| NDC | 61553-0672-44 |
Product
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
Reason for recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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-1089-2020. 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.