2 mcg/mL Fentanyl Citrate and 0 — Class II drug recall D-1396-2016
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-1396-2016 |
|---|---|
| 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 | 97,716 bags |
| Reason classes | foreign material, sterility, specification failure |
| NDC | 61553-0104-03, 61553-0124-48, 61553-0125-52, 61553-0204-37, 61553-0204-54, 61553-0205-02, 61553-0205-50, 61553-0205-97, 61553-0443-47, 61553-0491-30, 61553-0491-96, 61553-0802-96 |
| Lot numbers | 160380046M, 160380047C, 160380048M, 160380049C, 160380161M, 160380180M, 160380181M, 160380187M, 160380188M, 160380305M, 160390194M, 160400176M, 160400200M, 160400214M, 160410050M, 160410054C, 160410056C, 160410308M, 160420030M, 160420039M, 160420050C, 160420051C, 160420054M, 160420055M, 160420336M, 160420344M, 160420345M, 160450064C, 160450066M, 160450067M, 160450069C, 160450070C, 160450071C, 160450073C, 160450074C, 160450077M, 160450080M, 160450221M, 160450359M, 160460029C and 460 more |
| Expiration dates | 2016-05-06, 2016-05-07, 2016-05-08, 2016-05-09, 2016-05-10, 2016-05-11, 2016-05-12, 2016-05-13, 2016-05-14, 2016-05-15, 2016-05-16, 2016-05-17, 2016-05-18, 2016-05-19, 2016-05-20, 2016-05-21, 2016-05-22, 2016-05-23, 2016-05-24, 2016-05-25, 2016-05-26, 2016-05-27, 2016-05-28, 2016-05-29, 2016-05-30 and 38 more |
Product
2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2H8125 , NDC 61553-125-52 , 100 ml in 100 ml Hospira LifeCare Bag ; Service Code 2H8204 , NDC 61553-204-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8205 , NDC 61553-205-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8104 , NDC 61553-104-03 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K8124 , NDC 61553-124-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8204 , NDC 61553-204-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8205 , NDC 61553-205-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8443 , NDC 61553-443-47 , 150 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8491 , NDC 61553-491-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9491 , NDC 61553-491-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9802 , NDC 61553-802-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 4J8205 , NDC 61553-205-97 , 250 ml in 250 ml Baxter Intravia Bag ; 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-1396-2016. 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.