10 mcg/mL Fentanyl Citrate — Class II drug recall D-1043-2018
Terminated recall by PharMEDium Services, LLC, reported 2018-08-15, distributed nationwide. CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
| Recall number | D-1043-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PharMEDium Services, LLC, Dayton, NJ, United States |
| Recall initiated | 2018-07-24 |
| Classified | 2018-08-03 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2018-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 230 intravia |
| Reason classes | cgmp |
| Lot numbers | 181730007D, 181760013D |
| Expiration dates | 2018-08-09 |
Product
10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.
Reason for recall
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
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-1043-2018. 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.