Recalls / Class II

Class IID-1395-2016

Product

2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC 61553-201-58 , 200 ml in 250 ml Cormix Bag ; Service Code 2H8131 , NDC 61553-131-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8201 , NDC 61553-201-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8122 , NDC 61553-122-48 , 100 ml in 100 ml Baxter APII Bag ; Service Code 2K8123 , NDC 61553-123-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8131 , NDC 61553-131-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8201 , NDC 61553-201-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8442 , NDC 61553-442-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8490 , NDC 61553-490-47150 ml in 150 ml Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Affected lot / code info

Service Code 3V8701 , Lot Number 160390095M , Exp. Date 5/9/2016 ; Service Code 3V8701 , Lot Number 160480198M , Exp. Date 5/18/2016 ; Service Code 3V8701 , Lot Number 160540108M , Exp. Date 5/24/2016 ; Service Code 3V8701 , Lot Number 160690111M , Exp. Date 6/8/2016 ; Service Code 3V8701 , Lot Number 160740250M , Exp. Date 6/13/2016 ; Service Code 3V8701 , Lot Number 160820104M , Exp. Date 6/21/2016 ; Service Code 3V8701 , Lot Number 160900119M , Exp. Date 6/28/2016 ; Service Code 3V8701 , Lot Number 160970024M , Exp. Date 7/5/2016 ; Service Code 3V8703 , Lot Number 160420127M , Exp. Date 5/6/2016 ; Service Code 3V8703 , Lot Number 160460220M , Exp. Date 5/10/2016 ; Service Code 3V8703 , Lot Number 160530317M , Exp. Date 5/17/2016 ; Service Code 3V8703 , Lot Number 160540155M , Exp. Date 5/18/2016 ; Service Code 3V8703 , Lot Number 160630132M , Exp. Date 5/27/2016 ; Service Code 3V8703 , Lot Number 160660018C , Exp. Date 5/30/2016 ; Service Code 3V8703 , Lot Number 160660249M , Exp. Date 5/30/2016 ; Service Code 3V8703 , Lot Number 160750261M , Exp. Date 6/8/2016 ; Service Code 3V8703 , Lot Number 160800218M , Exp. Date 6/13/2016 ; Service Code 3V8703 , Lot Number 160910144M , Exp. Date 6/24/2016 ; Service Code 3V8703 , Lot Number 160940249M , Exp. Date 6/27/2016 ; Service Code 3V8703 , Lot Number 161080258M , Exp. Date 7/11/2016 ; Service Code 2C8201 , Lot Number 160960246M , Exp. Date 5/21/2016 ; Service Code 2H8122 , Lot Number 160400260M , Exp. Date 5/6/2016 ; Service Code 2H8122 , Lot Number 160460244M , Exp. Date 5/12/2016 ; Service Code 2H8122 , Lot Number 160530172M , Exp. Date 5/19/2016 ; Service Code 2H8122 , Lot Number 160600231M , Exp. Date 5/26/2016 ; Service Code 2H8122 , Lot Number 160610162M , Exp. Date 5/27/2016 ; Service Code 2H8122 , Lot Number 160660246M , Exp. Date 6/1/2016 ; Service Code 2H8122 , Lot Number 160680217M , Exp. Date 6/3/2016 ; Service Code 2H8122 , Lot Number 160770255M , Exp. Date 6/12/2016 ; Service Code 2H8122 , Lot Number 160800216M , Exp. Date 6/15/2016 ; Service Code 2H8122 , Lot Number 160890198M , Exp. Date 6/24/2016 ; Service Code 2H8122 , Lot Number 160910120M , Exp. Date 6/26/2016 ; Service Code 2H8122 , Lot Number 160940211M , Exp. Date 6/29/2016 ; Service Code 2H8131 , Lot Number 160390320M , Exp. Date 5/9/2016 ; Service Code 2H8131 , Lot Number 160460041M , Exp. Date 5/16/2016 ; Service Code 2H8131 , Lot Number 160480170M , Exp. Date 5/18/2016 ; Service Code 2H8131 , Lot Number 160530268M , Exp. Date 5/23/2016 ; Service Code 2H8131 , Lot Number 160600043M , Exp. Date 5/30/2016 ; Service Code 2H8131 , Lot Number 160660087M , Exp. Date 6/5/2016 ; Service Code 2H8131 , Lot Number 160700178M , Exp. Date 6/9/2016 ; Service Code 2H8131 , Lot Number 160750035M , Exp. Date 6/14/2016 ; Service Code 2H8131 , Lot Number 160810269M , Exp. Date 6/20/2016 ; Service Code 2H8131 , Lot Number 160870108M , Exp. Date 6/26/2016 ; Service Code 2H8131 , Lot Number 160900326M , Exp. Date 6/29/2016 ; Service Code 2H8131 , Lot Number 160960059M , Exp. Date 7/5/2016 ; Service Code 2H8201 , Lot Number 160600054M , Exp. Date 5/16/2016 ; Service Code 2H8201 , Lot Number 160670235M , Exp. Date 5/23/2016 ; Service Code 2H8201 , Lot Number 160740184M , Exp. Date 5/30/2016 ; Service Code 2H8201 , Lot Number 160890267M , Exp. Date 6/14/2016 ; Service Code 2H8201 , Lot Number 160950054M , Exp. Date 6/19/2016 ; Service Code 2H8201 , Lot Number 160960004M , Exp. Date 6/20/2016 ; Service Code 2K8122 , Lot Number 160410134M , Exp. Date 5/7/2016 ; Service Code 2K8122 , Lot Number 160460125M , Exp. Date 5/12/2016 ; Service Code 2K8122 , Lot Number 160520111M , Exp. Date 5/17/2016 ; Service Code 2K8122 , Lot Number 160620030M , Exp. Date 5/27/2016 ; Service Code 2K8122 , Lot Number 160670147M , Exp. Date 6/2/2016 ; Service Code 2K8122 , Lot Number 160740165M , Exp. Date 6/9/2016 ; Service Code 2K8122 , Lot Number 160820129M , Exp. Date 6/17/2016 ; Service Code 2K8122 , Lot Number 160900134M , Exp. Date 6/25/2016 ; Service Code 2K8122 , Lot Number 160960144M , Exp. Date 7/1/2016 ; Service Code 2K8123 , Lot Number 160420053C , Exp. Date 5/12/2016 ; Service Code 2K8123 , Lot Number 160420252M , Exp. Date 5/12/2016 ; Service Code 2K8123 , Lot Number 160450066C , Exp. Date 5/15/2016 ; Service Code 2K8123 , Lot Number 160460028M , Exp. Date 5/16/2016 ; Service Code 2K8123 , Lot Number 160460061C , Exp. Date 5/16/2016 ; Service Code 2K8123 , Lot Number 160530266M , Exp. Date 5/23/2016 ; Service Code 2K8123 , Lot Number 160550023C , Exp. Date 5/25/2016 ; Service Code 2K8123 , Lot Number 160550048M , Exp. Date 5/25/2016 ; Service Code 2K8123 , Lot Number 160600017C , Exp. Date 5/30/2016 ; Service Code 2K8123 , Lot Number 160600018C , Exp. Date 5/30/2016 ; Service Code 2K8123 , Lot Number 160600092M , Exp. Date 5/30/2016 ; Service Code 2K8123 , Lot Number 160630013C , Exp. Date 6/2/2016 ; Service Code 2K8123 , Lot Number 160660086M , Exp. Date 6/5/2016 ; Service Code 2K8123 , Lot Number 160670048C , Exp. Date 6/6/2016 ; Service Code 2K8123 , Lot Number 160680061M , Exp. Date 6/7/2016 ; Service Code 2K8123 , Lot Number 160730009C , Exp. Date 6/12/2016 ; Service Code 2K8123 , Lot Number 160730347M , Exp. Date 6/12/2016 ; Service Code 2K8123 , Lot Number 160740056C , Exp. Date 6/13/2016 ; Service Code 2K8123 , Lot Number 160770021C , Exp. Date 6/16/2016 ; Service Code 2K8123 , Lot Number 160810032M , Exp. Date 6/20/2016 ; Service Code 2K8123 , Lot Number 160820031C , Exp. Date 6/21/2016 ; Service Code 2K8123 , Lot Number 160840046C , Exp. Date 6/23/2016 ; Service Code 2K8123 , Lot Number 160870061C , Exp. Date 6/26/2016 ; Service Code 2K8123 , Lot Number 160870106M , Exp. Date 6/26/2016 ; Service Code 2K8123 , Lot Number 160880344M , Exp. Date 6/27/2016 ; Service Code 2K8123 , Lot Number 160890065C , Exp. Date 6/28/2016 ; Service Code 2K8123 , Lot Number 160900152C , Exp. Date 6/29/2016 ; Service Code 2K8123 , Lot Number 160910037M , Exp. Date 6/30/2016 ; Service Code 2K8123 , Lot Number 160970069C , Exp. Date 7/6/2016 ; Service Code 2K8123 , Lot Number 161080082M , Exp. Date 7/17/2016 ; Service Code 2K8131 , Lot Number 160420213M , Exp. Date 5/6/2016 ; Service Code 2K8131 , Lot Number 160450363M , Exp. Date 5/9/2016 ; Service Code 2K8131 , Lot Number 160460066C , Exp. Date 5/10/2016 ; Service Code 2K8131 , Lot Number 160480027C , Exp. Date 5/12/2016 ; Service Code 2K8131 , Lot Number 160490047M , Exp. Date 5/13/2016 ; Service Code 2K8131 , Lot Number 160520063C , Exp. Date 5/16/2016 ; Service Code 2K8131 , Lot Number 160520294M , Exp. Date 5/16/2016 ; Service Code 2K8131 , Lot Number 160540021C , Exp. Date 5/18/2016 ; Service Code 2K8131 , Lot Number 160550019C , Exp. Date 5/19/2016 ; Service Code 2K8131 , Lot Number 160560035M , Exp. Date 5/20/2016 ; Service Code 2K8131 , Lot Number 160560316M , Exp. Date 5/20/2016 ; Service Code 2K8131 , Lot Number 160590127M , Exp. Date 5/23/2016 ; Service Code 2K8131 , Lot Number 160600045C , Exp. Date 5/24/2016 ; Service Code 2K8131 , Lot Number 160600046C , Exp. Date 5/24/2016 ; Service Code 2K8131 , Lot Number 160610014C , Exp. Date 5/25/2016 ; Service Code 2K8131 , Lot Number 160620014C , Exp. Date 5/26/2016 ; Service Code 2K8131 , Lot Number 160620054M , Exp. Date 5/26/2016 ; Service Code 2K8131 , Lot Number 160620322M , Exp. Date 5/26/2016 ; Service Code 2K8131 , Lot Number 160660017C , Exp. Date 5/30/2016 ; Service Code 2K8131 , Lot Number 160660351M , Exp. Date 5/30/2016 ; Service Code 2K8131 , Lot Number 160680014C , Exp. Date 6/1/2016 ; Service Code 2K8131 , Lot Number 160690285M , Exp. Date 6/2/2016 ; Service Code 2K8131 , Lot Number 160740034M , Exp. Date 6/7/2016 ; Service Code 2K8131 , Lot Number 160740052C , Exp. Date 6/7/2016 ; Service Code 2K8131 , Lot Number 160740053C , Exp. Date 6/7/2016 ; Service Code 2K8131 , Lot Number 160740054M , Exp. Date 6/7/2016 ; Service Code 2K8131 , Lot Number 160750021C , Exp. Date 6/8/2016 ; Service Code 2K8131 , Lot Number 160750022C , Exp. Date 6/8/2016 ; Service Code 2K8131 , Lot Number 160760160M , Exp. Date 6/9/2016 ; Service Code 2K8131 , Lot Number 160770323M , Exp. Date 6/10/2016 ; Service Code 2K8131 , Lot Number 160800013C , Exp. Date 6/13/2016 ; Service Code 2K8131 , Lot Number 160810023C , Exp. Date 6/14/2016 ; Service Code 2K8131 , Lot Number 160810237M , Exp. Date 6/14/2016 ; Service Code 2K8131 , Lot Number 160820054C , Exp. Date 6/15/2016 ; Service Code 2K8131 , Lot Number 160820197M , Exp. Date 6/15/2016 ; Service Code 2K8131 , Lot Number 160820326M , Exp. Date 6/15/2016 ; Service Code 2K8131 , Lot Number 160840065C , Exp. Date 6/17/2016 ; Service Code 2K8131 , Lot Number 160870069C , Exp. Date 6/20/2016 ; Service Code 2K8131 , Lot Number 160870116M , Exp. Date 6/20/2016 ; Service Code 2K8131 , Lot Number 160880063M , Exp. Date 6/21/2016 ; Service Code 2K8131 , Lot Number 160890015C , Exp. Date 6/22/2016 ; Service Code 2K8131 , Lot Number 160890016C , Exp. Date 6/22/2016 ; Service Code 2K8131 , Lot Number 160900153C , Exp. Date 6/23/2016 ; Service Code 2K8131 , Lot Number 160910051M , Exp. Date 6/24/2016 ; Service Code 2K8131 , Lot Number 160910056C , Exp. Date 6/24/2016 ; Service Code 2K8131 , Lot Number 160910058C , Exp. Date 6/24/2016 ; Service Code 2K8131 , Lot Number 160940330M , Exp. Date 6/27/2016 ; Service Code 2K8131 , Lot Number 160950078M , Exp. Date 6/28/2016 ; Service Code 2K8131 , Lot Number 160960081C , Exp. Date 6/29/2016 ; Service Code 2K8201 , Lot Number 160420343M , Exp. Date 5/6/2016 ; Service Code 2K8201 , Lot Number 160460032M , Exp. Date 5/10/2016 ; Service Code 2K8201 , Lot Number 160520042M , Exp. Date 5/16/2016 ; Service Code 2K8201 , Lot Number 160540340M , Exp. Date 5/18/2016 ; Service Code 2K8201 , Lot Number 160600069M , Exp. Date 5/24/2016 ; Service Code 2K8201 , Lot Number 160630027M , Exp. Date 5/27/2016 ; Service Code 2K8201 , Lot Number 160670025M , Exp. Date 5/31/2016 ; Service Code 2K8201 , Lot Number 160680233M , Exp. Date 6/1/2016 ; Service Code 2K8201 , Lot Number 160740055M , Exp. Date 6/7/2016 ; Service Code 2K8201 , Lot Number 160810363M , Exp. Date 6/14/2016 ; Service Code 2K8201 , Lot Number 160870338M , Exp. Date 6/20/2016 ; Service Code 2K8201 , Lot Number 160890369M , Exp. Date 6/22/2016 ; Service Code 2K8201 , Lot Number 160950065M , Exp. Date 6/28/2016 ; Service Code 2K8442 , Lot Number 160460152M , Exp. Date 5/16/2016 ; Service Code 2K8442 , Lot Number 160600211M , Exp. Date 5/30/2016 ; Service Code 2K8442 , Lot Number 160610241M , Exp. Date 5/31/2016 ; Service Code 2K8442 , Lot Number 160740025M , Exp. Date 6/12/2016 ; Service Code 2K8442 , Lot Number 160750036M , Exp. Date 6/13/2016 ; Service Code 2K8442 , Lot Number 160960031M , Exp. Date 7/4/2016 ; Service Code 2K8442 , Lot Number 160970164M , Exp. Date 7/6/2016 ; Service Code 2K8490 , Lot Number 160390239M , Exp. Date 5/9/2016 ; Service Code 2K8490 , Lot Number 160490196M , Exp. Date 5/19/2016 ; Service Code 2K8490 , Lot Number 160660230M , Exp. Date 6/5/2016 ; Service Code 2K8490 , Lot Number 160770205M , Exp. Date 6/16/2016 ; Service Code 2K8490 , Lot Number 160800075M , Exp. Date 6/18/2016 ; Service Code 2K8490 , Lot Number 160810294M , Exp. Date 6/20/2016 ; Service Code 2K8490 , Lot Number 160870081M , Exp. Date 6/25/2016 ; Service Code 2K8490 , Lot Number 160950212M , Exp. Date 7/4/2016 ; Service Code 2K8689 , Lot Number 160410030M , Exp. Date 5/11/2016 ; Service Code 2K8689 , Lot Number 160490223M , Exp. Date 5/19/2016 ; Service Code 2K8689 , Lot Number 160490224M , Exp. Date 5/19/2016 ; Service Code 2K8689 , Lot Number 160540249M , Exp. Date 5/24/2016 ; Service Code 2K8689 , Lot Number 160620023M , Exp. Date 6/1/2016 ; Service Code 2K8689 , Lot Number 160660089M , Exp. Date 6/5/2016 ; Service Code 2K8689 , Lot Number 160680047M , Exp. Date 6/7/2016 ; Service Code 2K8689 , Lot Number 160730106M , Exp. Date 6/12/2016 ; Service Code 2K8689 , Lot Number 160760117M , Exp. Date 6/15/2016 ; Service Code 2K8689 , Lot Number 160820242M , Exp. Date 6/21/2016 ; Service Code 2K8689 , Lot Number 160870104M , Exp. Date 6/26/2016 ; Service Code 2K8689 , Lot Number 160890215M , Exp. Date 6/28/2016 ; Service Code 2K8689 , Lot Number 160950253M , Exp. Date 7/4/2016 ; Service Code 2K8803 , Lot Number 160530173M , Exp. Date 5/14/2016 ; Service Code 2K8803 , Lot Number 160740149M , Exp. Date 6/3/2016 ; Service Code 2K8803 , Lot Number 160800061M , Exp. Date 6/9/2016 ; Service Code 2K8803 , Lot Number 160880170M , Exp. Date 6/18/2016 ; Service Code 2K8803 , Lot Number 160950144M , Exp. Date 6/24/2016 ; Service Code 2K8804 , Lot Number 160450088M , Exp. Date 5/6/2016 ; Service Code 2K8804 , Lot Number 160460252M , Exp. Date 5/7/2016 ; Service Code 2K8804 , Lot Number 160460253M , Exp. Date 5/7/2016 ; Service Code 2K8804 , Lot Number 160460326M , Exp. Date 5/7/2016 ; Service Code 2K8804 , Lot Number 160460327M , Exp. Date 5/7/2016 ; Service Code 2K8804 , Lot Number 160490316M , Exp. Date 5/10/2016 ; Service Code 2K8804 , Lot Number 160530032M , Exp. Date 5/14/2016 ; Service Code 2K8804 , Lot Number 160540051M , Exp. Date 5/15/2016 ; Service Code 2K8804 , Lot Number 160540322M , Exp. Date 5/15/2016 ; Service Code 2K8804 , Lot Number 160560041M , Exp. Date 5/17/2016 ; Service Code 2K8804 , Lot Number 160590207M , Exp. Date 5/20/2016 ; Service Code 2K8804 , Lot Number 160610081M , Exp. Date 5/22/2016 ; Service Code 2K8804 , Lot Number 160620295M , Exp. Date 5/23/2016 ; Service Code 2K8804 , Lot Number 160630295M , Exp. Date 5/24/2016 ; Service Code 2K8804 , Lot Number 160660081M , Exp. Date 5/27/2016 ; Service Code 2K8804 , Lot Number 160660333M , Exp. Date 5/27/2016 ; Service Code 2K8804 , Lot Number 160680329M , Exp. Date 5/29/2016 ; Service Code 2K8804 , Lot Number 160700057M , Exp. Date 5/31/2016 ; Service Code 2K8804 , Lot Number 160700292M , Exp. Date 5/31/2016 ; Service Code 2K8804 , Lot Number 160730339M , Exp. Date 6/3/2016 ; Service Code 2K8804 , Lot Number 160750066M , Exp. Date 6/5/2016 ; Service Code 2K8804 , Lot Number 160750317M , Exp. Date 6/5/2016 ; Service Code 2K8804 , Lot Number 160760268M , Exp. Date 6/6/2016 ; Service Code 2K8804 , Lot Number 160800101M , Exp. Date 6/10/2016 ; Service Code 2K8804 , Lot Number 160800160M , Exp. Date 6/10/2016 ; Service Code 2K8804 , Lot Number 160810346M , Exp. Date 6/11/2016 ; Service Code 2K8804 , Lot Number 160820068M , Exp. Date 6/12/2016 ; Service Code 2K8804 , Lot Number 160840051M , Exp. Date 6/14/2016 ; Service Code 2K8804 , Lot Number 160870208M , Exp. Date 6/17/2016 ; Service Code 2K8804 , Lot Number 160890078M , Exp. Date 6/19/2016 ; Service Code 2K8804 , Lot Number 160910299M , Exp. Date 6/21/2016 ; Service Code 2K8804 , Lot Number 160940088M , Exp. Date 6/24/2016 ; Service Code 2K8804 , Lot Number 160950306M , Exp. Date 6/25/2016 ; Service Code 2K8804 , Lot Number 160960068M , Exp. Date 6/26/2016 ; Service Code 2K8804 , Lot Number 161080069M , Exp. Date 7/8/2016 ; Service Code 2K8804 , Lot Number 161080185M , Exp. Date 7/8/2016 ; Service Code 2K8863 , Lot Number 160480267M , Exp. Date 5/9/2016 ; Service Code 2K8863 , Lot Number 160600342M , Exp. Date 5/21/2016 ; Service Code 2K8863 , Lot Number 160620124M , Exp. Date 5/23/2016 ; Service Code 2K8863 , Lot Number 160740265M , Exp. Date 6/4/2016 ; Service Code 2K8863 , Lot Number 160800219M , Exp. Date 6/10/2016 ; Service Code 2K8863 , Lot Number 160870249M , Exp. Date 6/17/2016 ; Service Code 2K8863 , Lot Number 160900028M , Exp. Date 6/20/2016 ; Service Code 2K8863 , Lot Number 160940251M , Exp. Date 6/24/2016 ; Service Code 2K8869 , Lot Number 160450345M , Exp. Date 5/6/2016 ; Service Code 2K8869 , Lot Number 160490074M , Exp. Date 5/9/2016 ; Service Code 2K8869 , Lot Number 160520286M , Exp. Date 5/13/2016 ; Service Code 2K8869 , Lot Number 160550062M , Exp. Date 5/16/2016 ; Service Code 2K8869 , Lot Number 160550302M , Exp. Date 5/16/2016 ; Service Code 2K8869 , Lot Number 160560045M , Exp. Date 5/17/2016 ; Service Code 2K8869 , Lot Number 160560296M , Exp. Date 5/17/2016 ; Service Code 2K8869 , Lot Number 160610328M , Exp. Date 5/22/2016 ; Service Code 2K8869 , Lot Number 160620303M , Exp. Date 5/23/2016 ; Service Code 2K8869 , Lot Number 160660339M , Exp. Date 5/27/2016 ; Service Code 2K8869 , Lot Number 160670066C , Exp. Date 5/28/2016 ; Service Code 2K8869 , Lot Number 160680192M , Exp. Date 5/29/2016 ; Service Code 2K8869 , Lot Number 160680334M , Exp. Date 5/29/2016 ; Service Code 2K8869 , Lot Number 160700296M , Exp. Date 5/31/2016 ; Service Code 2K8869 , Lot Number 160730341M , Exp. Date 6/3/2016 ; Service Code 2K8869 , Lot Number 160750162M , Exp. Date 6/5/2016 ; Service Code 2K8869 , Lot Number 160750323M , Exp. Date 6/5/2016 ; Service Code 2K8869 , Lot Number 160800291M , Exp. Date 6/10/2016 ; Service Code 2K8869 , Lot Number 160820169M , Exp. Date 6/12/2016 ; Service Code 2K8869 , Lot Number 160820170M , Exp. Date 6/12/2016 ; Service Code 2K8869 , Lot Number 160830303M , Exp. Date 6/13/2016 ; Service Code 2K8869 , Lot Number 160840182M , Exp. Date 6/14/2016 ; Service Code 2K8869 , Lot Number 160840296M , Exp. Date 6/14/2016 ; Service Code 2K8869 , Lot Number 160880338M , Exp. Date 6/18/2016 ; Service Code 2K8869 , Lot Number 160900301M , Exp. Date 6/20/2016 ; Service Code 2K8869 , Lot Number 160900302M , Exp. Date 6/20/2016 ; Service Code 2K8869 , Lot Number 160950025C , Exp. Date 6/25/2016 ; Service Code 2K8869 , Lot Number 160950311M , Exp. Date 6/25/2016 ; Service Code 2K8869 , Lot Number 160960308M , Exp. Date 6/26/2016 ; Service Code 2K8869 , Lot Number 160970273M , Exp. Date 6/27/2016 ; Service Code 2K8869 , Lot Number 161080193M , Exp. Date 7/8/2016 ; Service Code 2K9201 , Lot Number 160490243M , Exp. Date 5/19/2016 ; Service Code 2T6122 , Lot Number 160830171M , Exp. Date 6/22/2016 ; Service Code 2T6122 , Lot Number 160950184M , Exp. Date 7/4/2016 ; Service Code 2T8201 , Lot Number 160960288M , Exp. Date 5/6/2016 ; Service Code 2T8201 , Lot Number 161080318M , Exp. Date 5/18/2016 ; Service Code 2T8869 , Lot Number 160960048C , Exp. Date 5/6/2016 ; Service Code 2T8869 , Lot Number 160960289M , Exp. Date 5/6/2016 ; Service Code 2T8869 , Lot Number 160970071M , Exp. Date 5/7/2016 ;

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

43,589 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-1395-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.