5 mcg/mL Fentanyl Citrate and 0 — Class II drug recall D-1425-206
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-1425-206 |
|---|---|
| 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 | 2,713 syringes |
| Reason classes | foreign material, sterility, specification failure |
| NDC | 61553-0257-20 |
| Lot numbers | 160410192M, 160420038C, 160450016C, 160450061M, 160450201M, 160460045C, 160470232M, 160480268M, 160490044C, 160520016C, 160520033C, 160530019C, 160530050C, 160590009C, 160590029C, 160590083M, 160600059C, 160600062C, 160600314M, 160620194M, 160630012C, 160630026C, 160630033C, 160630170M, 160660158M, 160670022C, 160670077C, 160690002M, 160690170M, 160690191M, 160700033C, 160700150M, 160730011C, 160730033C, 160740029C, 160740036M, 160740233M, 160760163M, 160770056C, 160770283M and 22 more |
| Expiration dates | 2016-05-06, 2016-05-09, 2016-05-10, 2016-05-11, 2016-05-12, 2016-05-13, 2016-05-14, 2016-05-15, 2016-05-16, 2016-05-20, 2016-05-21, 2016-05-22, 2016-05-23, 2016-05-24, 2016-05-27, 2016-05-28, 2016-05-29, 2016-05-30, 2016-05-31, 2016-06-01, 2016-06-02, 2016-06-03, 2016-06-06, 2016-06-07, 2016-06-08 and 20 more |
Product
5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20
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-1425-206. 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.