Recalls / Class II

Class IID-1423-2016

Product

5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8447 , NDC 61553-447-25 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9135 , NDC 61553-135-10 , 350 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9915 , NDC 61553-915-97 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 4J8136 , NDC 61553-136-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141,

Affected lot / code info: Service Code 2H8136 , Lot Number 160390196M , Exp. Date 5/9/2016 ; Service Code 2H8136 , Lot Number 160400231M , Exp. Date 5/10/2016 ; Service Code 2H8136 , Lot Number 160410114M , Exp. Date 5/11/2016 ; Service Code 2H8136 , Lot Number 160460187M , Exp. Date 5/16/2016 ; Service Code 2H8136 , Lot Number 160490237M , Exp. Date 5/19/2016 ; Service Code 2H8136 , Lot Number 160520172M , Exp. Date 5/22/2016 ; Service Code 2H8136 , Lot Number 160530288M , Exp. Date 5/23/2016 ; Service Code 2H8136 , Lot Number 160600186M , Exp. Date 5/30/2016 ; Service Code 2H8136 , Lot Number 160630207M , Exp. Date 6/2/2016 ; Service Code 2H8136 , Lot Number 160670243M , Exp. Date 6/6/2016 ; Service Code 2H8136 , Lot Number 160730070M , Exp. Date 6/11/2016 ; Service Code 2H8136 , Lot Number 160740213M , Exp. Date 6/13/2016 ; Service Code 2H8136 , Lot Number 160810151M , Exp. Date 6/20/2016 ; Service Code 2H8136 , Lot Number 160830114M , Exp. Date 6/22/2016 ; Service Code 2H8136 , Lot Number 160880266M , Exp. Date 6/27/2016 ; Service Code 2H8136 , Lot Number 160950223M , Exp. Date 7/4/2016 ; Service Code 2H8136 , Lot Number 160960179M , Exp. Date 7/5/2016 ; Service Code 2H8136 , Lot Number 161080119M , Exp. Date 7/17/2016 ; Service Code 2K8135 , Lot Number 160390318M , Exp. Date 5/9/2016 ; Service Code 2K8135 , Lot Number 160450256M , Exp. Date 5/15/2016 ; Service Code 2K8135 , Lot Number 160520144M , Exp. Date 5/22/2016 ; Service Code 2K8135 , Lot Number 160660248M , Exp. Date 6/5/2016 ; Service Code 2K8135 , Lot Number 160730089M , Exp. Date 6/12/2016 ; Service Code 2K8135 , Lot Number 160840235M , Exp. Date 6/23/2016 ; Service Code 2K8135 , Lot Number 160950175M , Exp. Date 7/4/2016 ; Service Code 2K8136 , Lot Number 160470209M , Exp. Date 5/11/2016 ; Service Code 2K8136 , Lot Number 160490159M , Exp. Date 5/13/2016 ; Service Code 2K8136 , Lot Number 160560128M , Exp. Date 5/20/2016 ; Service Code 2K8136 , Lot Number 160600250M , Exp. Date 5/24/2016 ; Service Code 2K8136 , Lot Number 160660268M , Exp. Date 5/30/2016 ; Service Code 2K8136 , Lot Number 160730128M , Exp. Date 6/6/2016 ; Service Code 2K8136 , Lot Number 160770110M , Exp. Date 6/10/2016 ; Service Code 2K8136 , Lot Number 160810309M , Exp. Date 6/14/2016 ; Service Code 2K8136 , Lot Number 160840046M , Exp. Date 6/17/2016 ; Service Code 2K8136 , Lot Number 160890166M , Exp. Date 6/22/2016 ; Service Code 2K8136 , Lot Number 160970110M , Exp. Date 6/30/2016 ; Service Code 2K8136 , Lot Number 161080316M , Exp. Date 7/11/2016 ; Service Code 2K8447 , Lot Number 160480124M , Exp. Date 5/12/2016 ; Service Code 2K8447 , Lot Number 160560102M , Exp. Date 5/19/2016 ; Service Code 2K8447 , Lot Number 160620043M , Exp. Date 5/25/2016 ; Service Code 2K8447 , Lot Number 160820219M , Exp. Date 6/15/2016 ; Service Code 2K8945 , Lot Number 160460179M , Exp. Date 5/6/2016 ; Service Code 2K8945 , Lot Number 160680052M , Exp. Date 5/28/2016 ; Service Code 2K8945 , Lot Number 160890253M , Exp. Date 6/19/2016 ; Service Code 2K8984 , Lot Number 160490124M , Exp. Date 5/9/2016 ; Service Code 2K8984 , Lot Number 160530219M , Exp. Date 5/14/2016 ; Service Code 2K8984 , Lot Number 160550193M , Exp. Date 5/15/2016 ; Service Code 2K8984 , Lot Number 160620141M , Exp. Date 5/23/2016 ; Service Code 2K8984 , Lot Number 160690159M , Exp. Date 5/30/2016 ; Service Code 2K8984 , Lot Number 160750189M , Exp. Date 6/5/2016 ; Service Code 2K8984 , Lot Number 160820117M , Exp. Date 6/11/2016 ; Service Code 2K8984 , Lot Number 161080172M , Exp. Date 7/8/2016 ; Service Code 2K9135 , Lot Number 160520112M , Exp. Date 5/16/2016 ; Service Code 2K9135 , Lot Number 160600209M , Exp. Date 5/24/2016 ; Service Code 2K9135 , Lot Number 160620189M , Exp. Date 5/26/2016 ; Service Code 2K9135 , Lot Number 160660051M , Exp. Date 5/29/2016 ; Service Code 2K9135 , Lot Number 160830126M , Exp. Date 6/15/2016 ; Service Code 2K9135 , Lot Number 160890180M , Exp. Date 6/22/2016 ; Service Code 2K9135 , Lot Number 160910126M , Exp. Date 6/24/2016 ; Service Code 2K9915 , Lot Number 160620026C , Exp. Date 5/26/2016 ; Service Code 2K9915 , Lot Number 160740050C , Exp. Date 6/7/2016 ; Service Code 2K9915 , Lot Number 160810059C , Exp. Date 6/15/2016 ; Service Code 2T6135 , Lot Number 160400229M , Exp. Date 5/10/2016 ; Service Code 2T6135 , Lot Number 160450178M , Exp. Date 5/15/2016 ; Service Code 2T6135 , Lot Number 160490241M , Exp. Date 5/19/2016 ; Service Code 2T6135 , Lot Number 160620220M , Exp. Date 6/1/2016 ; Service Code 2T6135 , Lot Number 160680050M , Exp. Date 6/6/2016 ; Service Code 2T6135 , Lot Number 160810281M , Exp. Date 6/20/2016 ; Service Code 2T6135 , Lot Number 160940052M , Exp. Date 7/2/2016 ; Service Code 2T6135 , Lot Number 160950068M , Exp. Date 7/4/2016 ; Service Code 4J8136 , Lot Number 160460142M , Exp. Date 5/10/2016 ; Service Code 4J8136 , Lot Number 160680034M , Exp. Date 5/31/2016 ; Service Code 4J8136 , Lot Number 160740033M , Exp. Date 6/6/2016 ; Service Code 4J8136 , Lot Number 160880020M , Exp. Date 6/20/2016 ; Service Code 4J8136 , Lot Number 160950048M , Exp. Date 6/27/2016 ;

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: 3,474 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-1423-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.