FDA Drug recall D-1396-2016
2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride
- FDA Drug
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 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-1396-2016 |
| 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
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
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Identifiers
| code_info | Service Code 3V8705 , Lot Number 160380161M , Exp. Date 5/8/2016 ; Service Code 3V8705 , Lot Number 160400200M , Exp.…Service Code 3V8705 , Lot Number 160380161M , Exp. Date 5/8/2016 ; Service Code 3V8705 , Lot Number 160400200M , Exp. Date 5/10/2016 ; Service Code 3V8705 , Lot Number 160460205M , Exp. Date 5/15/2016 ; Service Code 3V8705 , Lot Number 160530278M , Exp. Date 5/23/2016 ; Service Code 3V8705 , Lot Number 160610204M , Exp. Date 5/31/2016 ; Service Code 3V8705 , Lot Number 160630155M , Exp. Date 6/2/2016 ; Service Code 3V8705 , Lot Number 160700159M , Exp. Date 6/9/2016 ; Service Code 3V8705 , Lot Number 160770234M , Exp. Date 6/16/2016 ; Service Code 3V8705 , Lot Number 160800199M , Exp. Date 6/19/2016 ; Service Code 3V8705 , Lot Number 160840217M , Exp. Date 6/23/2016 ; Service Code 3V8705 , Lot Number 161080171M , Exp. Date 7/17/2016 ; Service Code 3V8707 , Lot Number 160460233M , Exp. Date 5/10/2016 ; Service Code 3V8707 , Lot Number 160530170M , Exp. Date 5/17/2016 ; Service Code 3V8707 , Lot Number 160660139M , Exp. Date 5/30/2016 ; Service Code 3V8707 , Lot Number 1606 |
|---|
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-1396-2016%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.