FDA Drug Recalls

Recalls / Class II

Class IID-1406-2016

Product

2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, flow stop free flow protection, Service Code 2K8972, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0972-48

Affected lot / code info
Service Code 2K8210 , Lot Number 160390175M , Exp. Date 5/9/2016 ; Service Code 2K8210 , Lot Number 160400226M , Exp. Date 5/10/2016 ; Service Code 2K8210 , Lot Number 160520170M , Exp. Date 5/22/2016 ; Service Code 2K8210 , Lot Number 160590066M , Exp. Date 5/29/2016 ; Service Code 2K8210 , Lot Number 160670046M , Exp. Date 6/5/2016 ; Service Code 2K8210 , Lot Number 160680006M , Exp. Date 6/6/2016 ; Service Code 2K8210 , Lot Number 160700027M , Exp. Date 6/8/2016 ; Service Code 2K8210 , Lot Number 160730069M , Exp. Date 6/11/2016 ; Service Code 2K8210 , Lot Number 160880217M , Exp. Date 6/27/2016 ; Service Code 2K8972 , Lot Number 160450177M , Exp. Date 5/6/2016 ; Service Code 2K8972 , Lot Number 160460196M , Exp. Date 5/7/2016 ; Service Code 2K8972 , Lot Number 160600082M , Exp. Date 5/20/2016 ; Service Code 2K8972 , Lot Number 160670061C , Exp. Date 5/28/2016 ; Service Code 2K8972 , Lot Number 160740067C , Exp. Date 6/4/2016 ; Service Code 2K8972 , Lot Number 160810085C , Exp. Date 6/11/2016 ; Service Code 2K8972 , Lot Number 160950188M , 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
220 Medical Cassettes
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-1406-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.