FDA Drug recall D-1365-2016

0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-19…

FDA Drug
Class II
terminated
Published 2016-07-27

On 2016-07-27 the FDA classified a Class II recall of 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-19… 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-1365-2016
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

0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 61553-169-01), 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 2C8192 , Lot Number 160830033M , Exp. Date 5/7/2016 ; Service Code 2H8192 , Lot Number 160380144M , Exp.… Service Code 2C8192 , Lot Number 160830033M , Exp. Date 5/7/2016 ; Service Code 2H8192 , Lot Number 160380144M , Exp. Date 5/8/2016 ; Service Code 2H8192 , Lot Number 160480178M , Exp. Date 5/18/2016 ; Service Code 2H8192 , Lot Number 160610225M , Exp. Date 5/31/2016 ; Service Code 2H8192 , Lot Number 160690186M , Exp. Date 6/8/2016 ; Service Code 2H8192 , Lot Number 160730071M , Exp. Date 6/12/2016 ; Service Code 2H8192 , Lot Number 160760041M , Exp. Date 6/14/2016 ; Service Code 2H8192 , Lot Number 160820212M , Exp. Date 6/21/2016 ; Service Code 2H8192 , Lot Number 160880171M , Exp. Date 6/27/2016 ; Service Code 2H8192 , Lot Number 160940141M , Exp. Date 7/3/2016 ; Service Code 2H8192 , Lot Number 160950053M , Exp. Date 7/3/2016 ; Service Code 2H8194 , Lot Number 160410184M , Exp. Date 5/11/2016 ; Service Code 2H8194 , Lot Number 160540217M , Exp. Date 5/24/2016 ; Service Code 2H8194 , Lot Number 160550223M , Exp. Date 5/25/2016 ; Service Code 2H8194 , Lot Number 160590

code_info

Service Code 2C8192 , Lot Number 160830033M , Exp. Date 5/7/2016 ; Service Code 2H8192 , Lot Number 160380144M , Exp.…

Service Code 2C8192 , Lot Number 160830033M , Exp. Date 5/7/2016 ; Service Code 2H8192 , Lot Number 160380144M , Exp. Date 5/8/2016 ; Service Code 2H8192 , Lot Number 160480178M , Exp. Date 5/18/2016 ; Service Code 2H8192 , Lot Number 160610225M , Exp. Date 5/31/2016 ; Service Code 2H8192 , Lot Number 160690186M , Exp. Date 6/8/2016 ; Service Code 2H8192 , Lot Number 160730071M , Exp. Date 6/12/2016 ; Service Code 2H8192 , Lot Number 160760041M , Exp. Date 6/14/2016 ; Service Code 2H8192 , Lot Number 160820212M , Exp. Date 6/21/2016 ; Service Code 2H8192 , Lot Number 160880171M , Exp. Date 6/27/2016 ; Service Code 2H8192 , Lot Number 160940141M , Exp. Date 7/3/2016 ; Service Code 2H8192 , Lot Number 160950053M , Exp. Date 7/3/2016 ; Service Code 2H8194 , Lot Number 160410184M , Exp. Date 5/11/2016 ; Service Code 2H8194 , Lot Number 160540217M , Exp. Date 5/24/2016 ; Service Code 2H8194 , Lot Number 160550223M , Exp. Date 5/25/2016 ; Service Code 2H8194 , Lot Number 160590

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-1365-2016%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.