FDA Drug recall D-1415-2016

3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Serv…

FDA Drug
Class II
terminated
Published 2016-07-27

On 2016-07-27 the FDA classified a Class II recall of 3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Serv… 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-1415-2016
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

3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8284 (NDC 61553-284-01), 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 2H8239 , Lot Number 160400232M , Exp. Date 5/10/2016 ; Service Code 2H8239 , Lot Number 160630193M , Exp.… Service Code 2H8239 , Lot Number 160400232M , Exp. Date 5/10/2016 ; Service Code 2H8239 , Lot Number 160630193M , Exp. Date 6/2/2016 ; Service Code 2K8239 , Lot Number 160520143M , Exp. Date 5/16/2016 ; Service Code 2K8239 , Lot Number 160530306M , Exp. Date 5/17/2016 ; Service Code 2K8239 , Lot Number 160610250M , Exp. Date 5/25/2016 ; Service Code 2K8239 , Lot Number 160630167M , Exp. Date 5/27/2016 ; Service Code 2K8239 , Lot Number 160680214M , Exp. Date 6/1/2016 ; Service Code 2K8239 , Lot Number 160750241M , Exp. Date 6/8/2016 ; Service Code 2K8239 , Lot Number 160820181M , Exp. Date 6/15/2016 ; Service Code 2K8239 , Lot Number 160840225M , Exp. Date 6/17/2016 ; Service Code 2K8239 , Lot Number 160900186M , Exp. Date 6/23/2016 ; Service Code 2K8239 , Lot Number 160940234M , Exp. Date 6/27/2016 ; Service Code 2K8239 , Lot Number 161080183M , Exp. Date 7/11/2016 ; Service Code 2K8284 , Lot Number 160470223M , Exp. Date 5/17/2016 ; Service Code 2K8284 , Lot Number 1605

code_info

Service Code 2H8239 , Lot Number 160400232M , Exp. Date 5/10/2016 ; Service Code 2H8239 , Lot Number 160630193M , Exp.…

Service Code 2H8239 , Lot Number 160400232M , Exp. Date 5/10/2016 ; Service Code 2H8239 , Lot Number 160630193M , Exp. Date 6/2/2016 ; Service Code 2K8239 , Lot Number 160520143M , Exp. Date 5/16/2016 ; Service Code 2K8239 , Lot Number 160530306M , Exp. Date 5/17/2016 ; Service Code 2K8239 , Lot Number 160610250M , Exp. Date 5/25/2016 ; Service Code 2K8239 , Lot Number 160630167M , Exp. Date 5/27/2016 ; Service Code 2K8239 , Lot Number 160680214M , Exp. Date 6/1/2016 ; Service Code 2K8239 , Lot Number 160750241M , Exp. Date 6/8/2016 ; Service Code 2K8239 , Lot Number 160820181M , Exp. Date 6/15/2016 ; Service Code 2K8239 , Lot Number 160840225M , Exp. Date 6/17/2016 ; Service Code 2K8239 , Lot Number 160900186M , Exp. Date 6/23/2016 ; Service Code 2K8239 , Lot Number 160940234M , Exp. Date 6/27/2016 ; Service Code 2K8239 , Lot Number 161080183M , Exp. Date 7/11/2016 ; Service Code 2K8284 , Lot Number 160470223M , Exp. Date 5/17/2016 ; Service Code 2K8284 , Lot Number 1605

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-1415-2016%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.