FDA Drug recall D-1364-2016

0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-…

FDA Drug
Class II
terminated
Published 2016-07-27

On 2016-07-27 the FDA classified a Class II recall of 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-… 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-1364-2016
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

0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8272(NDC 61553-272-52), 100 ml in 100 ml Yellow Smiths Medical Cassette Service Code 2K8941 (NDC 61553-941-48), 250 ml in 250 ml Baxter Intravia Bag (W/O Additive Cap) Service Code 3V8716, (NDC 61553-716-17), 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 2K8195 , Lot Number 160390084M , Exp. Date 5/9/2016 ; Service Code 2K8195 , Lot Number 160530298M , Exp.… Service Code 2K8195 , Lot Number 160390084M , Exp. Date 5/9/2016 ; Service Code 2K8195 , Lot Number 160530298M , Exp. Date 5/23/2016 ; Service Code 2K8195 , Lot Number 160540203M , Exp. Date 5/24/2016 ; Service Code 2K8195 , Lot Number 160550182M , Exp. Date 5/25/2016 ; Service Code 2K8195 , Lot Number 160590153M , Exp. Date 5/29/2016 ; Service Code 2K8195 , Lot Number 160660150M , Exp. Date 6/5/2016 ; Service Code 2K8195 , Lot Number 160740115M , Exp. Date 6/12/2016 ; Service Code 2K8195 , Lot Number 160810295M , Exp. Date 6/20/2016 ; Service Code 2K8195 , Lot Number 160820217M , Exp. Date 6/21/2016 ; Service Code 2K8195 , Lot Number 160830164M , Exp. Date 6/21/2016 ; Service Code 2K8195 , Lot Number 160950236M , Exp. Date 7/4/2016 ; Service Code 2K8195 , Lot Number 160970203M , Exp. Date 7/6/2016 ; Service Code 2H8266 , Lot Number 160410177M , Exp. Date 5/11/2016 ; Service Code 2H8266 , Lot Number 160600056M , Exp. Date 5/29/2016 ; Service Code 2H8266 , Lot Number 16074

code_info

Service Code 2K8195 , Lot Number 160390084M , Exp. Date 5/9/2016 ; Service Code 2K8195 , Lot Number 160530298M , Exp.…

Service Code 2K8195 , Lot Number 160390084M , Exp. Date 5/9/2016 ; Service Code 2K8195 , Lot Number 160530298M , Exp. Date 5/23/2016 ; Service Code 2K8195 , Lot Number 160540203M , Exp. Date 5/24/2016 ; Service Code 2K8195 , Lot Number 160550182M , Exp. Date 5/25/2016 ; Service Code 2K8195 , Lot Number 160590153M , Exp. Date 5/29/2016 ; Service Code 2K8195 , Lot Number 160660150M , Exp. Date 6/5/2016 ; Service Code 2K8195 , Lot Number 160740115M , Exp. Date 6/12/2016 ; Service Code 2K8195 , Lot Number 160810295M , Exp. Date 6/20/2016 ; Service Code 2K8195 , Lot Number 160820217M , Exp. Date 6/21/2016 ; Service Code 2K8195 , Lot Number 160830164M , Exp. Date 6/21/2016 ; Service Code 2K8195 , Lot Number 160950236M , Exp. Date 7/4/2016 ; Service Code 2K8195 , Lot Number 160970203M , Exp. Date 7/6/2016 ; Service Code 2H8266 , Lot Number 160410177M , Exp. Date 5/11/2016 ; Service Code 2H8266 , Lot Number 160600056M , Exp. Date 5/29/2016 ; Service Code 2H8266 , Lot Number 16074

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-1364-2016%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.