FDA Drug recall D-1397-2016

2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Serv…

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 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Serv… 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-1397-2016
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 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K8433, NDC 61553-433-58, 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	Lot Number 160470226M , Exp. Date 5/11/2016 ; Lot Number 160540237M , Exp. Date 5/18/2016 ; Lot Number 160600045M , E… Lot Number 160470226M , Exp. Date 5/11/2016 ; Lot Number 160540237M , Exp. Date 5/18/2016 ; Lot Number 160600045M , Exp. Date 5/23/2016 ; Lot Number 160750052M , Exp. Date 6/7/2016 ; Lot Number 160950043M , Exp. Date 6/27/2016 ;

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-1397-2016%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.