FDA Drug recall D-1432-2016

6.66 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 6.66 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-1432-2016
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

6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-993-86

Reason

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

Identifiers

code_info	Lot Number 160480035C , Exp. Date 5/18/2016 ; Lot Number 160560026C , Exp. Date 5/26/2016 ; Lot Number 160620029C , E… Lot Number 160480035C , Exp. Date 5/18/2016 ; Lot Number 160560026C , Exp. Date 5/26/2016 ; Lot Number 160620029C , Exp. Date 6/1/2016 ; Lot Number 160630001C , Exp. Date 6/1/2016 ; Lot Number 160810283M , Exp. Date 6/20/2016 ; Lot Number 160880013C , Exp. Date 6/27/2016 ; Lot Number 160890043C , Exp. Date 6/28/2016 ;

code_info

Lot Number 160480035C , Exp. Date 5/18/2016 ; Lot Number 160560026C , Exp. Date 5/26/2016 ; Lot Number 160620029C , E…

Lot Number 160480035C , Exp. Date 5/18/2016 ; Lot Number 160560026C , Exp. Date 5/26/2016 ; Lot Number 160620029C , Exp. Date 6/1/2016 ; Lot Number 160630001C , Exp. Date 6/1/2016 ; Lot Number 160810283M , Exp. Date 6/20/2016 ; Lot Number 160880013C , Exp. Date 6/27/2016 ; Lot Number 160890043C , Exp. Date 6/28/2016 ;

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-1432-2016%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.