FDA Drug recall D-1422-2016

5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Ser…

FDA Drug
Class II
terminated
Published 2016-07-27

On 2016-07-27 the FDA classified a Class II recall of 5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Ser… 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-1422-2016
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

5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 ,

Reason

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Identifiers

code_info	Service Code 2H8256 , Lot Number 160410124M , Exp. Date 5/11/2016 ; Service Code 2H8256 , Lot Number 160560146M , Exp.… Service Code 2H8256 , Lot Number 160410124M , Exp. Date 5/11/2016 ; Service Code 2H8256 , Lot Number 160560146M , Exp. Date 5/26/2016 ; Service Code 2H8256 , Lot Number 160590041M , Exp. Date 5/29/2016 ; Service Code 2H8256 , Lot Number 160690131M , Exp. Date 6/8/2016 ; Service Code 2H8256 , Lot Number 160900157M , Exp. Date 6/29/2016 ; Service Code 2K8254 , Lot Number 160390176M , Exp. Date 5/9/2016 ; Service Code 2K8254 , Lot Number 160410129M , Exp. Date 5/11/2016 ; Service Code 2K8254 , Lot Number 160460130M , Exp. Date 5/16/2016 ; Service Code 2K8254 , Lot Number 160530293M , Exp. Date 5/23/2016 ; Service Code 2K8254 , Lot Number 160590075M , Exp. Date 5/29/2016 ; Service Code 2K8254 , Lot Number 160600187M , Exp. Date 5/30/2016 ; Service Code 2K8254 , Lot Number 160610002M , Exp. Date 5/30/2016 ; Service Code 2K8254 , Lot Number 160680155M , Exp. Date 6/6/2016 ; Service Code 2K8254 , Lot Number 160760125M , Exp. Date 6/14/2016 ; Service Code 2K8254 , Lot Number 1608

code_info

Service Code 2H8256 , Lot Number 160410124M , Exp. Date 5/11/2016 ; Service Code 2H8256 , Lot Number 160560146M , Exp.…

Service Code 2H8256 , Lot Number 160410124M , Exp. Date 5/11/2016 ; Service Code 2H8256 , Lot Number 160560146M , Exp. Date 5/26/2016 ; Service Code 2H8256 , Lot Number 160590041M , Exp. Date 5/29/2016 ; Service Code 2H8256 , Lot Number 160690131M , Exp. Date 6/8/2016 ; Service Code 2H8256 , Lot Number 160900157M , Exp. Date 6/29/2016 ; Service Code 2K8254 , Lot Number 160390176M , Exp. Date 5/9/2016 ; Service Code 2K8254 , Lot Number 160410129M , Exp. Date 5/11/2016 ; Service Code 2K8254 , Lot Number 160460130M , Exp. Date 5/16/2016 ; Service Code 2K8254 , Lot Number 160530293M , Exp. Date 5/23/2016 ; Service Code 2K8254 , Lot Number 160590075M , Exp. Date 5/29/2016 ; Service Code 2K8254 , Lot Number 160600187M , Exp. Date 5/30/2016 ; Service Code 2K8254 , Lot Number 160610002M , Exp. Date 5/30/2016 ; Service Code 2K8254 , Lot Number 160680155M , Exp. Date 6/6/2016 ; Service Code 2K8254 , Lot Number 160760125M , Exp. Date 6/14/2016 ; Service Code 2K8254 , Lot Number 1608

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-1422-2016%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.