FDA Drug recall D-1392-2016
2 mcg/mL Fentanyl Citrate and 0.075% 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 0.075% 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-1392-2016 |
| 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 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), 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 2K9226 , Lot Number 160450145M , Exp. Date 5/9/2016 ; Service Code 2K9226 , Lot Number 160530166M , Exp.…Service Code 2K9226 , Lot Number 160450145M , Exp. Date 5/9/2016 ; Service Code 2K9226 , Lot Number 160530166M , Exp. Date 5/17/2016 ; Service Code 2K9226 , Lot Number 160560080M , Exp. Date 5/19/2016 ; Service Code 2K9226 , Lot Number 160670164M , Exp. Date 5/31/2016 ; Service Code 2K9226 , Lot Number 160730130M , Exp. Date 6/6/2016 ; Service Code 2K9226 , Lot Number 160770032M , Exp. Date 6/10/2016 ; Service Code 2K9226 , Lot Number 160810035M , Exp. Date 6/13/2016 ; Service Code 2K9226 , Lot Number 160820135M , Exp. Date 6/15/2016 ; Service Code 2K9226 , Lot Number 160870152M , Exp. Date 6/20/2016 ; Service Code 2K9226 , Lot Number 160890036M , Exp. Date 6/22/2016 ; Service Code 2K9226 , Lot Number 160950040M , Exp. Date 6/27/2016 ; Service Code 2K9294 , Lot Number 160400210M , Exp. Date 5/10/2016 ; Service Code 2K9294 , Lot Number 160700164M , Exp. Date 6/9/2016 ; |
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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-1392-2016%22
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