5 mcg/mL Fentanyl Citrate and 0 — Class II drug recall D-1423-2016
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-1423-2016 |
|---|---|
| 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 | 3,474 bags |
| Reason classes | foreign material, sterility, specification failure |
| NDC | 61553-0135-10, 61553-0135-48, 61553-0136-02, 61553-0136-97, 61553-0447-25, 61553-0915-97 |
| Lot numbers | 160390196M, 160390318M, 160400229M, 160400231M, 160410114M, 160450178M, 160450256M, 160460142M, 160460179M, 160460187M, 160470209M, 160480124M, 160490124M, 160490159M, 160490237M, 160490241M, 160520112M, 160520144M, 160520172M, 160530219M, 160530288M, 160550193M, 160560102M, 160560128M, 160600186M, 160600209M, 160600250M, 160620026C, 160620043M, 160620141M, 160620189M, 160620220M, 160630207M, 160660051M, 160660248M, 160660268M, 160670243M, 160680034M, 160680050M, 160680052M and 35 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, 2016-05-19, 2016-05-20, 2016-05-22, 2016-05-23, 2016-05-24, 2016-05-25, 2016-05-26, 2016-05-28, 2016-05-29, 2016-05-30, 2016-05-31, 2016-06-01, 2016-06-02, 2016-06-05, 2016-06-06, 2016-06-07 and 20 more |
Product
5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8447 , NDC 61553-447-25 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9135 , NDC 61553-135-10 , 350 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9915 , NDC 61553-915-97 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 4J8136 , NDC 61553-136-97 , 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-1423-2016. 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.