3 mcg/mL Fentanyl Citrate and 0 — Class II drug recall D-1415-2016
Terminated recall by Pharmedium Services, LLC, reported 2016-07-27, distributed nationwide. Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable
| Recall number | D-1415-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmedium Services, LLC, Lake Forest, IL, United States |
| Recall initiated | 2016-05-05 |
| Classified | 2016-07-16 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2018-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 1,470 bags |
| Reason classes | foreign material, sterility, specification failure |
| NDC | 61553-0239-02, 61553-0239-50, 61553-0284-01 |
| Lot numbers | 160400232M, 160470223M, 160520118M, 160520143M, 160530306M, 160610207M, 160610250M, 160620153M, 160630167M, 160630193M, 160680214M, 160750236M, 160750241M, 160770226M, 160820181M, 160840209M, 160840225M, 160900186M, 160910218M, 160940234M, 160960157M, 161080183M, 161080227M |
| Expiration dates | 2016-05-10, 2016-05-16, 2016-05-17, 2016-05-22, 2016-05-25, 2016-05-27, 2016-05-31, 2016-06-01, 2016-06-02, 2016-06-08, 2016-06-14, 2016-06-15, 2016-06-16, 2016-06-17, 2016-06-23, 2016-06-27, 2016-06-30, 2016-07-05, 2016-07-11, 2016-07-17 |
Product
3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8284 (NDC 61553-284-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Reason for recall
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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-1415-2016. 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.