FDA Drug recall D-1423-2016
5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 ,…
- FDA Drug
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of 5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 ,… by Pharmedium Services, citing presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1423-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-05 |
| Published | 2016-07-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmedium Services |
| Distribution | US |
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
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Identifiers
| code_info | Service Code 2H8136 , Lot Number 160390196M , Exp. Date 5/9/2016 ; Service Code 2H8136 , Lot Number 160400231M , Exp.…Service Code 2H8136 , Lot Number 160390196M , Exp. Date 5/9/2016 ; Service Code 2H8136 , Lot Number 160400231M , Exp. Date 5/10/2016 ; Service Code 2H8136 , Lot Number 160410114M , Exp. Date 5/11/2016 ; Service Code 2H8136 , Lot Number 160460187M , Exp. Date 5/16/2016 ; Service Code 2H8136 , Lot Number 160490237M , Exp. Date 5/19/2016 ; Service Code 2H8136 , Lot Number 160520172M , Exp. Date 5/22/2016 ; Service Code 2H8136 , Lot Number 160530288M , Exp. Date 5/23/2016 ; Service Code 2H8136 , Lot Number 160600186M , Exp. Date 5/30/2016 ; Service Code 2H8136 , Lot Number 160630207M , Exp. Date 6/2/2016 ; Service Code 2H8136 , Lot Number 160670243M , Exp. Date 6/6/2016 ; Service Code 2H8136 , Lot Number 160730070M , Exp. Date 6/11/2016 ; Service Code 2H8136 , Lot Number 160740213M , Exp. Date 6/13/2016 ; Service Code 2H8136 , Lot Number 160810151M , Exp. Date 6/20/2016 ; Service Code 2H8136 , Lot Number 160830114M , Exp. Date 6/22/2016 ; Service Code 2H8136 , Lot Number 1608 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1423-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.