FDA Drug recall D-1391-2016

2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Se…

FDA Drug
Class II
terminated
Published 2016-07-27

On 2016-07-27 the FDA classified a Class II recall of 2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Se… 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-1391-2016
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

2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9966, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-966-95

Reason

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

Identifiers

code_info	Service Code 2K9966 , Lot Number 160390021M , Exp. Date 5/9/2016 ; Service Code 2K9966 , Lot Number 160450151M , Exp.… Service Code 2K9966 , Lot Number 160390021M , Exp. Date 5/9/2016 ; Service Code 2K9966 , Lot Number 160450151M , Exp. Date 5/15/2016 ; Service Code 2K9966 , Lot Number 160610223M , Exp. Date 5/31/2016 ; Service Code 2K9966 , Lot Number 160660080M , Exp. Date 6/5/2016 ; Service Code 2K9966 , Lot Number 160880210M , Exp. Date 6/27/2016 ; Service Code 2K9966 , Lot Number 160890277M , Exp. Date 6/28/2016 ; Service Code 2K9966 , Lot Number 160910004M , Exp. Date 6/29/2016 ; Service Code 3V8709 , Lot Number 160550119M , Exp. Date 5/19/2016 ; Service Code 3V8709 , Lot Number 160630116M , Exp. Date 5/27/2016 ; Service Code 3V8709 , Lot Number 160750050M , Exp. Date 6/7/2016 ; Service Code 3V8709 , Lot Number 160890054M , Exp. Date 6/21/2016 ; Service Code 3V8724 , Lot Number 160390325M , Exp. Date 5/9/2016 ; Service Code 3V8724 , Lot Number 160600304M , Exp. Date 5/30/2016 ; Service Code 3V8724 , Lot Number 160770031M , Exp. Date 6/15/2016 ; Service Code 3V8724 , Lot Number 16088

code_info

Service Code 2K9966 , Lot Number 160390021M , Exp. Date 5/9/2016 ; Service Code 2K9966 , Lot Number 160450151M , Exp.…

Service Code 2K9966 , Lot Number 160390021M , Exp. Date 5/9/2016 ; Service Code 2K9966 , Lot Number 160450151M , Exp. Date 5/15/2016 ; Service Code 2K9966 , Lot Number 160610223M , Exp. Date 5/31/2016 ; Service Code 2K9966 , Lot Number 160660080M , Exp. Date 6/5/2016 ; Service Code 2K9966 , Lot Number 160880210M , Exp. Date 6/27/2016 ; Service Code 2K9966 , Lot Number 160890277M , Exp. Date 6/28/2016 ; Service Code 2K9966 , Lot Number 160910004M , Exp. Date 6/29/2016 ; Service Code 3V8709 , Lot Number 160550119M , Exp. Date 5/19/2016 ; Service Code 3V8709 , Lot Number 160630116M , Exp. Date 5/27/2016 ; Service Code 3V8709 , Lot Number 160750050M , Exp. Date 6/7/2016 ; Service Code 3V8709 , Lot Number 160890054M , Exp. Date 6/21/2016 ; Service Code 3V8724 , Lot Number 160390325M , Exp. Date 5/9/2016 ; Service Code 3V8724 , Lot Number 160600304M , Exp. Date 5/30/2016 ; Service Code 3V8724 , Lot Number 160770031M , Exp. Date 6/15/2016 ; Service Code 3V8724 , Lot Number 16088

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-1391-2016%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.