5 mcg/mL Fentanyl Citrate and 0 — Class II drug recall D-1426-2016
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-1426-2016 |
|---|---|
| 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 | 3,927 syringes |
| Reason classes | foreign material, sterility, specification failure |
| NDC | 61553-0140-20, 61553-0222-31 |
| Lot numbers | 160380106M, 160400202M, 160420160M, 160420171M, 160450047M, 160450175M, 160450212M, 160460111M, 160460122M, 160460151M, 160460193M, 160460213M, 160470188M, 160480240M, 160490001M, 160490225M, 160520182M, 160520185M, 160530289M, 160540193M, 160540244M, 160540245M, 160550237M, 160560083M, 160560094M, 160560215M, 160590055M, 160590141M, 160590188M, 160600050M, 160600232M, 160610189M, 160610248M, 160620192M, 160630129M, 160630156M, 160660143M, 160660153M, 160660222M, 160670159M and 44 more |
| Expiration dates | 2016-05-06, 2016-05-07, 2016-05-09, 2016-05-10, 2016-05-11, 2016-05-12, 2016-05-13, 2016-05-15, 2016-05-16, 2016-05-17, 2016-05-18, 2016-05-21, 2016-05-22, 2016-05-23, 2016-05-24, 2016-05-25, 2016-05-26, 2016-05-27, 2016-05-29, 2016-05-30, 2016-05-31, 2016-06-01, 2016-06-02, 2016-06-05, 2016-06-06 and 23 more |
Product
5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), 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-1426-2016. 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.