Recalls / Class II

Class IID-1391-2016

Product

2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9966, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-966-95

Affected lot / code info: Service Code 2K9966 , Lot Number 160390021M , Exp. Date 5/9/2016 ; Service Code 2K9966 , Lot Number 160450151M , Exp. Date 5/15/2016 ; Service Code 2K9966 , Lot Number 160610223M , Exp. Date 5/31/2016 ; Service Code 2K9966 , Lot Number 160660080M , Exp. Date 6/5/2016 ; Service Code 2K9966 , Lot Number 160880210M , Exp. Date 6/27/2016 ; Service Code 2K9966 , Lot Number 160890277M , Exp. Date 6/28/2016 ; Service Code 2K9966 , Lot Number 160910004M , Exp. Date 6/29/2016 ; Service Code 3V8709 , Lot Number 160550119M , Exp. Date 5/19/2016 ; Service Code 3V8709 , Lot Number 160630116M , Exp. Date 5/27/2016 ; Service Code 3V8709 , Lot Number 160750050M , Exp. Date 6/7/2016 ; Service Code 3V8709 , Lot Number 160890054M , Exp. Date 6/21/2016 ; Service Code 3V8724 , Lot Number 160390325M , Exp. Date 5/9/2016 ; Service Code 3V8724 , Lot Number 160600304M , Exp. Date 5/30/2016 ; Service Code 3V8724 , Lot Number 160770031M , Exp. Date 6/15/2016 ; Service Code 3V8724 , Lot Number 160880271M , Exp. Date 6/27/2016 ; Service Code 2H8129 , Lot Number 160540238M , Exp. Date 5/20/2016 ; Service Code 2H8129 , Lot Number 160590104M , Exp. Date 5/25/2016 ; Service Code 2H8129 , Lot Number 160660247M , Exp. Date 6/1/2016 ; Service Code 2H8129 , Lot Number 160730274M , Exp. Date 6/8/2016 ; Service Code 2H8129 , Lot Number 160810226M , Exp. Date 6/16/2016 ; Service Code 2H8129 , Lot Number 160840032M , Exp. Date 6/19/2016 ; Service Code 2H8129 , Lot Number 160940173M , Exp. Date 6/29/2016 ; Service Code 2H8129 , Lot Number 161080115M , Exp. Date 7/13/2016 ; Service Code 2H8132 , Lot Number 160390248M , Exp. Date 5/9/2016 ; Service Code 2H8132 , Lot Number 160460217M , Exp. Date 5/16/2016 ; Service Code 2H8132 , Lot Number 160490227M , Exp. Date 5/19/2016 ; Service Code 2H8132 , Lot Number 160530175M , Exp. Date 5/23/2016 ; Service Code 2H8132 , Lot Number 160600229M , Exp. Date 5/30/2016 ; Service Code 2H8132 , Lot Number 160660244M , Exp. Date 6/5/2016 ; Service Code 2H8132 , Lot Number 160700169M , Exp. Date 6/9/2016 ; Service Code 2H8132 , Lot Number 160750149M , Exp. Date 6/14/2016 ; Service Code 2H8132 , Lot Number 160830147M , Exp. Date 6/22/2016 ; Service Code 2H8132 , Lot Number 160890269M , Exp. Date 6/28/2016 ; Service Code 2H8132 , Lot Number 160940240M , Exp. Date 7/3/2016 ; Service Code 2K8121 , Lot Number 160380131M , Exp. Date 5/8/2016 ; Service Code 2K8121 , Lot Number 160410135M , Exp. Date 5/11/2016 ; Service Code 2K8121 , Lot Number 160490155M , Exp. Date 5/19/2016 ; Service Code 2K8121 , Lot Number 160550154M , Exp. Date 5/25/2016 ; Service Code 2K8121 , Lot Number 160600215M , Exp. Date 5/30/2016 ; Service Code 2K8121 , Lot Number 160660234M , Exp. Date 6/5/2016 ; Service Code 2K8121 , Lot Number 160730257M , Exp. Date 6/12/2016 ; Service Code 2K8121 , Lot Number 160800137M , Exp. Date 6/19/2016 ; Service Code 2K8121 , Lot Number 160830143M , Exp. Date 6/22/2016 ; Service Code 2K8121 , Lot Number 160910135M , Exp. Date 6/30/2016 ; Service Code 2K8121 , Lot Number 160940233M , Exp. Date 7/3/2016 ; Service Code 2K8132 , Lot Number 160420102M , Exp. Date 5/6/2016 ; Service Code 2K8132 , Lot Number 160420214M , Exp. Date 5/6/2016 ; Service Code 2K8132 , Lot Number 160420342M , Exp. Date 5/6/2016 ; Service Code 2K8132 , Lot Number 160450074M , Exp. Date 5/9/2016 ; Service Code 2K8132 , Lot Number 160450075M , Exp. Date 5/9/2016 ; Service Code 2K8132 , Lot Number 160450364M , Exp. Date 5/9/2016 ; Service Code 2K8132 , Lot Number 160470314M , Exp. Date 5/11/2016 ; Service Code 2K8132 , Lot Number 160480039M , Exp. Date 5/12/2016 ; Service Code 2K8132 , Lot Number 160520295M , Exp. Date 5/16/2016 ; Service Code 2K8132 , Lot Number 160530061M , Exp. Date 5/17/2016 ; Service Code 2K8132 , Lot Number 160550332M , Exp. Date 5/19/2016 ; Service Code 2K8132 , Lot Number 160550333M , Exp. Date 5/19/2016 ; Service Code 2K8132 , Lot Number 160590128M , Exp. Date 5/23/2016 ; Service Code 2K8132 , Lot Number 160610345M , Exp. Date 5/25/2016 ; Service Code 2K8132 , Lot Number 160620323M , Exp. Date 5/26/2016 ; Service Code 2K8132 , Lot Number 160630049M , Exp. Date 5/27/2016 ; Service Code 2K8132 , Lot Number 160630311M , Exp. Date 5/27/2016 ; Service Code 2K8132 , Lot Number 160660105M , Exp. Date 5/30/2016 ; Service Code 2K8132 , Lot Number 160670059M , Exp. Date 5/31/2016 ; Service Code 2K8132 , Lot Number 160680062M , Exp. Date 6/1/2016 ; Service Code 2K8132 , Lot Number 160690053M , Exp. Date 6/2/2016 ; Service Code 2K8132 , Lot Number 160700311M , Exp. Date 6/3/2016 ; Service Code 2K8132 , Lot Number 160730118M , Exp. Date 6/6/2016 ; Service Code 2K8132 , Lot Number 160750058M , Exp. Date 6/8/2016 ; Service Code 2K8132 , Lot Number 160760291M , Exp. Date 6/9/2016 ; Service Code 2K8132 , Lot Number 160770324M , Exp. Date 6/10/2016 ; Service Code 2K8132 , Lot Number 160800122M , Exp. Date 6/13/2016 ; Service Code 2K8132 , Lot Number 160810238M , Exp. Date 6/14/2016 ; Service Code 2K8132 , Lot Number 160820044M , Exp. Date 6/15/2016 ; Service Code 2K8132 , Lot Number 160820079M , Exp. Date 6/15/2016 ; Service Code 2K8132 , Lot Number 160820080M , Exp. Date 6/15/2016 ; Service Code 2K8132 , Lot Number 160830059M , Exp. Date 6/16/2016 ; Service Code 2K8132 , Lot Number 160870117M , Exp. Date 6/20/2016 ; Service Code 2K8132 , Lot Number 160870336M , Exp. Date 6/20/2016 ; Service Code 2K8132 , Lot Number 160880064M , Exp. Date 6/21/2016 ; Service Code 2K8132 , Lot Number 160890069M , Exp. Date 6/22/2016 ; Service Code 2K8132 , Lot Number 160890367M , Exp. Date 6/22/2016 ; Service Code 2K8132 , Lot Number 160890368M , Exp. Date 6/22/2016 ; Service Code 2K8132 , Lot Number 160900057M , Exp. Date 6/23/2016 ; Service Code 2K8132 , Lot Number 160910324M , Exp. Date 6/24/2016 ; Service Code 2K8132 , Lot Number 160950330M , Exp. Date 6/28/2016 ; Service Code 2K8132 , Lot Number 160960326M , Exp. Date 6/29/2016 ; Service Code 2K8132 , Lot Number 160970297M , Exp. Date 6/30/2016 ; Service Code 2K8132 , Lot Number 161090001M , Exp. Date 7/11/2016 ; Service Code 2K8639 , Lot Number 160420251M , Exp. Date 5/12/2016 ; Service Code 2K8639 , Lot Number 160490106M , Exp. Date 5/18/2016 ; Service Code 2K8639 , Lot Number 160550111M , Exp. Date 5/24/2016 ; Service Code 2K8639 , Lot Number 160600305M , Exp. Date 5/30/2016 ; Service Code 2K8639 , Lot Number 160730255M , Exp. Date 6/12/2016 ; Service Code 2K8639 , Lot Number 160800207M , Exp. Date 6/19/2016 ; Service Code 2K8639 , Lot Number 160830196M , Exp. Date 6/22/2016 ; Service Code 2K8639 , Lot Number 160900151M , Exp. Date 6/29/2016 ; Service Code 2K8639 , Lot Number 161080236M , Exp. Date 7/17/2016 ; Service Code 2K8862 , Lot Number 160610069M , Exp. Date 5/21/2016 ; Service Code 2K8862 , Lot Number 160630040M , Exp. Date 5/23/2016 ; Service Code 2K8862 , Lot Number 160670182M , Exp. Date 5/28/2016 ; Service Code 2K8862 , Lot Number 160680046M , Exp. Date 5/28/2016 ; Service Code 2K8862 , Lot Number 160800056M , Exp. Date 6/9/2016 ; Service Code 2K8862 , Lot Number 160840030M , Exp. Date 6/13/2016 ; Service Code 2K8862 , Lot Number 160840126M , Exp. Date 6/14/2016 ; Service Code 2K8862 , Lot Number 160870048M , Exp. Date 6/16/2016 ; Service Code 2K8862 , Lot Number 160940149M , Exp. Date 6/24/2016 ; Service Code 2K8862 , Lot Number 160950029C , Exp. Date 6/25/2016 ; Service Code 2K8862 , Lot Number 160960240M , Exp. Date 6/26/2016 ; Service Code 2K8966 , Lot Number 160830024C , Exp. Date 6/13/2016 ; Service Code 2K9121 , Lot Number 160460255M , Exp. Date 5/16/2016 ; Service Code 2K9121 , Lot Number 160600258M , Exp. Date 5/30/2016 ; Service Code 2K9121 , Lot Number 160600259M , Exp. Date 5/30/2016 ; Service Code 2K9121 , Lot Number 160600260M , Exp. Date 5/30/2016 ; Service Code 2K9121 , Lot Number 160750165M , Exp. Date 6/14/2016 ; Service Code 2K9121 , Lot Number 160750166M , Exp. Date 6/14/2016 ; Service Code 2K9132 , Lot Number 160450014C , Exp. Date 5/9/2016 ; Service Code 2K9132 , Lot Number 160520015C , Exp. Date 5/16/2016 ; Service Code 2K9132 , Lot Number 160600001C , Exp. Date 5/23/2016 ; Service Code 2K9132 , Lot Number 160670015C , Exp. Date 5/31/2016 ; Service Code 2K9132 , Lot Number 160730005C , Exp. Date 6/6/2016 ; Service Code 2K9132 , Lot Number 160800021C , Exp. Date 6/13/2016 ; Service Code 2K9132 , Lot Number 160870006C , Exp. Date 6/20/2016 ; Service Code 2K9132 , Lot Number 160940120M , Exp. Date 6/27/2016 ; Service Code 2K9132 , Lot Number 161080116M , Exp. Date 7/11/2016 ; Service Code 2T8862 , Lot Number 160960238M , Exp. Date 5/6/2016 ; Service Code 2T8862 , Lot Number 160970116M , Exp. Date 5/6/2016 ;

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: 17,990 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-1391-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.