Recalls / Class II

Class IID-1425-206

Product

5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20

Affected lot / code info

Service Code 2H8138 , Lot Number 160410192M , Exp. Date 5/11/2016 ; Service Code 2H8138 , Lot Number 160600314M , Exp. Date 5/30/2016 ; Service Code 2H8138 , Lot Number 160690002M , Exp. Date 6/7/2016 ; Service Code 2H8138 , Lot Number 160690191M , Exp. Date 6/8/2016 ; Service Code 2H8138 , Lot Number 160740233M , Exp. Date 6/13/2016 ; Service Code 2H8138 , Lot Number 160760163M , Exp. Date 6/14/2016 ; Service Code 2H8138 , Lot Number 160830226M , Exp. Date 6/22/2016 ; Service Code 2H8138 , Lot Number 160890256M , Exp. Date 6/28/2016 ; Service Code 2H8138 , Lot Number 160940138M , Exp. Date 7/3/2016 ; Service Code 2H8138 , Lot Number 160960197M , Exp. Date 7/5/2016 ; Service Code 2H8138 , Lot Number 161080219M , Exp. Date 7/17/2016 ; Service Code 2K8138 , Lot Number 160450061M , Exp. Date 5/9/2016 ; Service Code 2K8138 , Lot Number 160470232M , Exp. Date 5/11/2016 ; Service Code 2K8138 , Lot Number 160480268M , Exp. Date 5/12/2016 ; Service Code 2K8138 , Lot Number 160590083M , Exp. Date 5/23/2016 ; Service Code 2K8138 , Lot Number 160630170M , Exp. Date 5/27/2016 ; Service Code 2K8138 , Lot Number 160690170M , Exp. Date 6/2/2016 ; Service Code 2K8138 , Lot Number 160700150M , Exp. Date 6/3/2016 ; Service Code 2K8138 , Lot Number 160770283M , Exp. Date 6/10/2016 ; Service Code 2K8138 , Lot Number 160840146M , Exp. Date 6/17/2016 ; Service Code 2K8138 , Lot Number 160910269M , Exp. Date 6/24/2016 ; Service Code 2K8138 , Lot Number 161080325M , Exp. Date 7/11/2016 ; Service Code 2K8807 , Lot Number 160490044C , Exp. Date 5/10/2016 ; Service Code 2K8807 , Lot Number 160630012C , Exp. Date 5/24/2016 ; Service Code 2K8807 , Lot Number 160700033C , Exp. Date 5/31/2016 ; Service Code 2K8807 , Lot Number 160970033C , Exp. Date 6/27/2016 ; Service Code 2K8872 , Lot Number 160600059C , Exp. Date 5/21/2016 ; Service Code 2K8872 , Lot Number 160630026C , Exp. Date 5/24/2016 ; Service Code 2K8872 , Lot Number 160660158M , Exp. Date 5/27/2016 ; Service Code 2K8872 , Lot Number 160740036M , Exp. Date 6/3/2016 ; Service Code 2K8872 , Lot Number 160880252M , Exp. Date 6/18/2016 ; Service Code 2K8872 , Lot Number 160940031C , Exp. Date 6/24/2016 ; Service Code 2K9138 , Lot Number 160420038C , Exp. Date 5/12/2016 ; Service Code 2K9138 , Lot Number 160460045C , Exp. Date 5/16/2016 ; Service Code 2K9138 , Lot Number 160520033C , Exp. Date 5/22/2016 ; Service Code 2K9138 , Lot Number 160530050C , Exp. Date 5/23/2016 ; Service Code 2K9138 , Lot Number 160590029C , Exp. Date 5/29/2016 ; Service Code 2K9138 , Lot Number 160600062C , Exp. Date 5/30/2016 ; Service Code 2K9138 , Lot Number 160630033C , Exp. Date 6/2/2016 ; Service Code 2K9138 , Lot Number 160670077C , Exp. Date 6/6/2016 ; Service Code 2K9138 , Lot Number 160730033C , Exp. Date 6/12/2016 ; Service Code 2K9138 , Lot Number 160770056C , Exp. Date 6/16/2016 ; Service Code 2K9138 , Lot Number 160880076C , Exp. Date 6/27/2016 ; Service Code 2K9138 , Lot Number 160910024C , Exp. Date 6/30/2016 ; Service Code 2K9138 , Lot Number 160950084C , Exp. Date 7/4/2016 ; Service Code 2K9138 , Lot Number 160960054C , Exp. Date 7/5/2016 ; Service Code 2T6257 , Lot Number 160450201M , Exp. Date 5/15/2016 ; Service Code 2T6257 , Lot Number 160620194M , Exp. Date 6/1/2016 ; Service Code 2T6257 , Lot Number 160810203M , Exp. Date 6/20/2016 ; Service Code 2T6257 , Lot Number 160820230M , Exp. Date 6/21/2016 ; Service Code 2T6257 , Lot Number 160870153M , Exp. Date 6/26/2016 ; Service Code 2T6257 , Lot Number 160880278M , Exp. Date 6/27/2016 ; Service Code 2T6257 , Lot Number 160950233M , Exp. Date 7/4/2016 ; Service Code 2T8141 , Lot Number 160450016C , Exp. Date 5/6/2016 ; Service Code 2T8141 , Lot Number 160520016C , Exp. Date 5/13/2016 ; Service Code 2T8141 , Lot Number 160530019C , Exp. Date 5/14/2016 ; Service Code 2T8141 , Lot Number 160590009C , Exp. Date 5/20/2016 ; Service Code 2T8141 , Lot Number 160670022C , Exp. Date 5/28/2016 ; Service Code 2T8141 , Lot Number 160730011C , Exp. Date 6/3/2016 ; Service Code 2T8141 , Lot Number 160740029C , Exp. Date 6/3/2016 ; Service Code 2T8141 , Lot Number 160800022C , Exp. Date 6/10/2016 ; Service Code 2T8141 , Lot Number 160870008C , Exp. Date 6/17/2016 ;

Why it was recalled

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

Recalling firm

Firm

Pharmedium Services, LLC

Notification channel

E-Mail

Type

Voluntary: Firm initiated

Address

150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506

Distribution

Quantity

2,713 syringes

Distribution pattern

Nationwide

Timeline

Recall initiated

2016-05-05

FDA classified

2016-07-16

Posted by FDA

2016-07-27

Terminated

2018-03-06

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1425-206. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.