FDA Drug recall D-1420-2016

4 mcg/mL Fentanyl Citrate and 0.125% 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 4 mcg/mL Fentanyl Citrate and 0.125% 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-1420-2016
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

4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop, free-flow protection, Service Code 2T8214, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-214-48

Reason

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

Identifiers

code_info	Service Code 2K8130 , Lot Number 160450167M , Exp. Date 5/9/2016 ; Service Code 2K8130 , Lot Number 160460113M , Exp.… Service Code 2K8130 , Lot Number 160450167M , Exp. Date 5/9/2016 ; Service Code 2K8130 , Lot Number 160460113M , Exp. Date 5/10/2016 ; Service Code 2K8130 , Lot Number 160490184M , Exp. Date 5/13/2016 ; Service Code 2K8130 , Lot Number 160540122M , Exp. Date 5/17/2016 ; Service Code 2K8130 , Lot Number 160590163M , Exp. Date 5/23/2016 ; Service Code 2K8130 , Lot Number 160610226M , Exp. Date 5/25/2016 ; Service Code 2K8130 , Lot Number 160630185M , Exp. Date 5/27/2016 ; Service Code 2K8130 , Lot Number 160670242M , Exp. Date 5/31/2016 ; Service Code 2K8130 , Lot Number 160680239M , Exp. Date 6/1/2016 ; Service Code 2K8130 , Lot Number 160730147M , Exp. Date 6/6/2016 ; Service Code 2K8130 , Lot Number 160750140M , Exp. Date 6/8/2016 ; Service Code 2K8130 , Lot Number 160770169M , Exp. Date 6/10/2016 ; Service Code 2K8130 , Lot Number 160820223M , Exp. Date 6/15/2016 ; Service Code 2K8130 , Lot Number 160840161M , Exp. Date 6/17/2016 ; Service Code 2K8130 , Lot Number 16085

code_info

Service Code 2K8130 , Lot Number 160450167M , Exp. Date 5/9/2016 ; Service Code 2K8130 , Lot Number 160460113M , Exp.…

Service Code 2K8130 , Lot Number 160450167M , Exp. Date 5/9/2016 ; Service Code 2K8130 , Lot Number 160460113M , Exp. Date 5/10/2016 ; Service Code 2K8130 , Lot Number 160490184M , Exp. Date 5/13/2016 ; Service Code 2K8130 , Lot Number 160540122M , Exp. Date 5/17/2016 ; Service Code 2K8130 , Lot Number 160590163M , Exp. Date 5/23/2016 ; Service Code 2K8130 , Lot Number 160610226M , Exp. Date 5/25/2016 ; Service Code 2K8130 , Lot Number 160630185M , Exp. Date 5/27/2016 ; Service Code 2K8130 , Lot Number 160670242M , Exp. Date 5/31/2016 ; Service Code 2K8130 , Lot Number 160680239M , Exp. Date 6/1/2016 ; Service Code 2K8130 , Lot Number 160730147M , Exp. Date 6/6/2016 ; Service Code 2K8130 , Lot Number 160750140M , Exp. Date 6/8/2016 ; Service Code 2K8130 , Lot Number 160770169M , Exp. Date 6/10/2016 ; Service Code 2K8130 , Lot Number 160820223M , Exp. Date 6/15/2016 ; Service Code 2K8130 , Lot Number 160840161M , Exp. Date 6/17/2016 ; Service Code 2K8130 , Lot Number 16085

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-1420-2016%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.