Recalls / Class II

Class IID-1417-2016

Product

3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8470, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-470-30

Affected lot / code info

Lot Number 160390336M , Exp. Date 5/9/2016 ; Lot Number 160530318M , Exp. Date 5/23/2016 ; Lot Number 160600347M , Exp. Date 5/30/2016 ; Lot Number 160750243M , Exp. Date 6/14/2016 ; Lot Number 160760164M , Exp. Date 6/14/2016 ; Lot Number 160830228M , Exp. Date 6/22/2016 ; Lot Number 160890224M , Exp. Date 6/28/2016 ; Lot Number 160960242M , Exp. Date 7/5/2016 ; Lot Number 160970140M , Exp. Date 7/6/2016 ;

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

1,015 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-1417-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.