Recalls / Class II

Class IID-1405-2016

Product

2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Affected lot / code info

Service Code 2H8255 , Lot Number 160550161M , Exp. Date 5/11/2016 ; Service Code 2H8255 , Lot Number 160620170M , Exp. Date 5/18/2016 ; Service Code 2H8255 , Lot Number 160760132M , Exp. Date 6/1/2016 ; Service Code 2H8255 , Lot Number 160830148M , Exp. Date 6/8/2016 ; Service Code 2H8255 , Lot Number 160900158M , Exp. Date 6/15/2016 ; Service Code 2H8255 , Lot Number 160970139M , Exp. Date 6/22/2016 ; Service Code 2K8255 , Lot Number 160490046C , Exp. Date 5/13/2016 ; Service Code 2K8255 , Lot Number 160620032C , Exp. Date 5/26/2016 ; Service Code 2K8255 , Lot Number 160770046C , Exp. Date 6/10/2016 ; Service Code 2K8464 , Lot Number 160420154M , Exp. Date 5/6/2016 ; Service Code 2K8464 , Lot Number 160530249M , Exp. Date 5/17/2016 ; Service Code 2K8464 , Lot Number 160540207M , Exp. Date 5/18/2016 ; Service Code 2K8464 , Lot Number 160660045M , Exp. Date 5/29/2016 ; Service Code 2K8464 , Lot Number 160730092M , Exp. Date 6/6/2016 ; Service Code 2K8464 , Lot Number 160840137M , Exp. Date 6/17/2016 ; Service Code 2K8464 , Lot Number 160910145M , Exp. Date 6/24/2016 ; Service Code 2T8255 , Lot Number 160480271M , Exp. Date 5/9/2016 ; Service Code 2T8255 , Lot Number 160530302M , Exp. Date 5/14/2016 ; Service Code 2T8255 , Lot Number 160600047C , Exp. Date 5/21/2016 ; Service Code 2T8255 , Lot Number 160610032C , Exp. Date 5/22/2016 ; Service Code 2T8255 , Lot Number 160700030C , Exp. Date 5/30/2016 ; Service Code 2T8255 , Lot Number 160700031C , Exp. Date 5/31/2016 ; Service Code 2T8255 , Lot Number 160740060C , Exp. Date 6/4/2016 ; Service Code 2T8255 , Lot Number 160770034C , Exp. Date 6/7/2016 ; Service Code 2T8255 , Lot Number 160830059C , Exp. Date 6/13/2016 ; Service Code 2T8255 , Lot Number 160880040C , Exp. Date 6/18/2016 ; Service Code 2T8255 , Lot Number 160880041C , Exp. Date 6/18/2016 ; Service Code 2T8255 , Lot Number 160940029C , Exp. Date 6/24/2016 ; Service Code 2T8255 , Lot Number 160950051C , Exp. Date 6/25/2016 ;

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

2,006 bags

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-1405-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.