Recalls / Class II

Class IID-1365-2016

Product

0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 61553-169-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Affected lot / code info: Service Code 2C8192 , Lot Number 160830033M , Exp. Date 5/7/2016 ; Service Code 2H8192 , Lot Number 160380144M , Exp. Date 5/8/2016 ; Service Code 2H8192 , Lot Number 160480178M , Exp. Date 5/18/2016 ; Service Code 2H8192 , Lot Number 160610225M , Exp. Date 5/31/2016 ; Service Code 2H8192 , Lot Number 160690186M , Exp. Date 6/8/2016 ; Service Code 2H8192 , Lot Number 160730071M , Exp. Date 6/12/2016 ; Service Code 2H8192 , Lot Number 160760041M , Exp. Date 6/14/2016 ; Service Code 2H8192 , Lot Number 160820212M , Exp. Date 6/21/2016 ; Service Code 2H8192 , Lot Number 160880171M , Exp. Date 6/27/2016 ; Service Code 2H8192 , Lot Number 160940141M , Exp. Date 7/3/2016 ; Service Code 2H8192 , Lot Number 160950053M , Exp. Date 7/3/2016 ; Service Code 2H8194 , Lot Number 160410184M , Exp. Date 5/11/2016 ; Service Code 2H8194 , Lot Number 160540217M , Exp. Date 5/24/2016 ; Service Code 2H8194 , Lot Number 160550223M , Exp. Date 5/25/2016 ; Service Code 2H8194 , Lot Number 160590170M , Exp. Date 5/29/2016 ; Service Code 2H8194 , Lot Number 160630202M , Exp. Date 6/2/2016 ; Service Code 2H8194 , Lot Number 160660049M , Exp. Date 6/4/2016 ; Service Code 2H8194 , Lot Number 160740150M , Exp. Date 6/13/2016 ; Service Code 2H8194 , Lot Number 160750224M , Exp. Date 6/14/2016 ; Service Code 2H8194 , Lot Number 160760187M , Exp. Date 6/15/2016 ; Service Code 2H8194 , Lot Number 160810145M , Exp. Date 6/19/2016 ; Service Code 2H8194 , Lot Number 160840152M , Exp. Date 6/23/2016 ; Service Code 2H8194 , Lot Number 160870050M , Exp. Date 6/25/2016 ; Service Code 2H8194 , Lot Number 160880248M , Exp. Date 6/27/2016 ; Service Code 2H8194 , Lot Number 160900001M , Exp. Date 6/28/2016 ; Service Code 2H8194 , Lot Number 160910151M , Exp. Date 6/30/2016 ; Service Code 2H8194 , Lot Number 160950209M , Exp. Date 7/4/2016 ; Service Code 2H8194 , Lot Number 160960222M , Exp. Date 7/5/2016 ; Service Code 2H8194 , Lot Number 161080218M , Exp. Date 7/17/2016 ; Service Code 2K8117 , Lot Number 160390199M , Exp. Date 5/9/2016 ; Service Code 2K8117 , Lot Number 160450108M , Exp. Date 5/15/2016 ; Service Code 2K8117 , Lot Number 160530282M , Exp. Date 5/23/2016 ; Service Code 2K8117 , Lot Number 160600287M , Exp. Date 5/30/2016 ; Service Code 2K8117 , Lot Number 160670229M , Exp. Date 6/6/2016 ; Service Code 2K8117 , Lot Number 160730046M , Exp. Date 6/11/2016 ; Service Code 2K8117 , Lot Number 160880218M , Exp. Date 6/27/2016 ; Service Code 2K8117 , Lot Number 160950211M , Exp. Date 7/4/2016 ; Service Code 2K8169 , Lot Number 160380140M , Exp. Date 5/8/2016 ; Service Code 2K8169 , Lot Number 160540205M , Exp. Date 5/24/2016 ; Service Code 2K8169 , Lot Number 160550192M , Exp. Date 5/25/2016 ; Service Code 2K8169 , Lot Number 160600071M , Exp. Date 5/30/2016 ; Service Code 2K8169 , Lot Number 160750182M , Exp. Date 6/14/2016 ; Service Code 2K8169 , Lot Number 160820048M , Exp. Date 6/20/2016 ; Service Code 2K8169 , Lot Number 160950042M , Exp. Date 7/3/2016 ; Service Code 2K8191 , Lot Number 160450060M , Exp. Date 5/14/2016 ; Service Code 2K8191 , Lot Number 160520050M , Exp. Date 5/21/2016 ; Service Code 2K8191 , Lot Number 160590082M , Exp. Date 5/29/2016 ; Service Code 2K8191 , Lot Number 160660148M , Exp. Date 6/5/2016 ; Service Code 2K8191 , Lot Number 160740190M , Exp. Date 6/13/2016 ; Service Code 2K8191 , Lot Number 160770248M , Exp. Date 6/16/2016 ; Service Code 2K8191 , Lot Number 160840226M , Exp. Date 6/23/2016 ; Service Code 2K8191 , Lot Number 160890194M , Exp. Date 6/28/2016 ; Service Code 2K8191 , Lot Number 160940236M , Exp. Date 7/3/2016 ; Service Code 2K8192 , Lot Number 160380092M , Exp. Date 5/8/2016 ; Service Code 2K8192 , Lot Number 160410238M , Exp. Date 5/11/2016 ; Service Code 2K8192 , Lot Number 160450076M , Exp. Date 5/15/2016 ; Service Code 2K8192 , Lot Number 160490050M , Exp. Date 5/19/2016 ; Service Code 2K8192 , Lot Number 160550039M , Exp. Date 5/25/2016 ; Service Code 2K8192 , Lot Number 160560317M , Exp. Date 5/26/2016 ; Service Code 2K8192 , Lot Number 160610063M , Exp. Date 5/31/2016 ; Service Code 2K8192 , Lot Number 160620324M , Exp. Date 6/1/2016 ; Service Code 2K8192 , Lot Number 160690057M , Exp. Date 6/8/2016 ; Service Code 2K8192 , Lot Number 160750125M , Exp. Date 6/14/2016 ; Service Code 2K8192 , Lot Number 160750126M , Exp. Date 6/14/2016 ; Service Code 2K8192 , Lot Number 160810039M , Exp. Date 6/20/2016 ; Service Code 2K8192 , Lot Number 160810239M , Exp. Date 6/20/2016 ; Service Code 2K8192 , Lot Number 160840048M , Exp. Date 6/23/2016 ; Service Code 2K8192 , Lot Number 160870337M , Exp. Date 6/26/2016 ; Service Code 2K8192 , Lot Number 160910053M , Exp. Date 6/30/2016 ; Service Code 2K8192 , Lot Number 160950331M , Exp. Date 7/4/2016 ; Service Code 2K8192 , Lot Number 160970298M , Exp. Date 7/6/2016 ; Service Code 2K8294 , Lot Number 160390214M , Exp. Date 5/9/2016 ; Service Code 2K8294 , Lot Number 160420153M , Exp. Date 5/11/2016 ; Service Code 2K8294 , Lot Number 160470179M , Exp. Date 5/17/2016 ; Service Code 2K8294 , Lot Number 160480224M , Exp. Date 5/18/2016 ; Service Code 2K8294 , Lot Number 160540201M , Exp. Date 5/24/2016 ; Service Code 2K8294 , Lot Number 160550225M , Exp. Date 5/25/2016 ; Service Code 2K8294 , Lot Number 160610240M , Exp. Date 5/31/2016 ; Service Code 2K8294 , Lot Number 160620116M , Exp. Date 6/1/2016 ; Service Code 2K8294 , Lot Number 160670192M , Exp. Date 6/6/2016 ; Service Code 2K8294 , Lot Number 160730159M , Exp. Date 6/12/2016 ; Service Code 2K8294 , Lot Number 160740236M , Exp. Date 6/13/2016 ; Service Code 2K8294 , Lot Number 160750217M , Exp. Date 6/14/2016 ; Service Code 2K8294 , Lot Number 160760191M , Exp. Date 6/15/2016 ; Service Code 2K8294 , Lot Number 160810209M , Exp. Date 6/20/2016 ; Service Code 2K8294 , Lot Number 160820204M , Exp. Date 6/21/2016 ; Service Code 2K8294 , Lot Number 160830177M , Exp. Date 6/22/2016 ; Service Code 2K8294 , Lot Number 160840105M , Exp. Date 6/22/2016 ; Service Code 2K8294 , Lot Number 160900165M , Exp. Date 6/29/2016 ; Service Code 2K8294 , Lot Number 160910116M , Exp. Date 6/29/2016 ; Service Code 2K8294 , Lot Number 160960226M , Exp. Date 7/5/2016 ; Service Code 2K8294 , Lot Number 161080230M , Exp. Date 7/17/2016 ; Service Code 2K8829 , Lot Number 160600054C , Exp. Date 5/9/2016 ; Service Code 2K8829 , Lot Number 160620028C , Exp. Date 5/11/2016 ; Service Code 2K8829 , Lot Number 160670050C , Exp. Date 5/16/2016 ; Service Code 2K8829 , Lot Number 160680048C , Exp. Date 5/17/2016 ; Service Code 2K8829 , Lot Number 160740061C , Exp. Date 5/23/2016 ; Service Code 2K8829 , Lot Number 160810072C , Exp. Date 5/30/2016 ; Service Code 2K8829 , Lot Number 160870029C , Exp. Date 6/5/2016 ; Service Code 2K8829 , Lot Number 160950049C , Exp. Date 6/13/2016 ; Service Code 2K8881 , Lot Number 160670060C , Exp. Date 5/16/2016 ; Service Code 2K8881 , Lot Number 160740062C , Exp. Date 5/23/2016 ; Service Code 2K8881 , Lot Number 160810068C , Exp. Date 5/30/2016 ; Service Code 2K8881 , Lot Number 160880036C , Exp. Date 6/6/2016 ; Service Code 2K8881 , Lot Number 160910019C , Exp. Date 6/9/2016 ; Service Code 2K8881 , Lot Number 160950074C , Exp. Date 6/13/2016 ; Service Code 2K8882 , Lot Number 160620027C , Exp. Date 5/11/2016 ; Service Code 2K8882 , Lot Number 160760043C , Exp. Date 5/25/2016 ; Service Code 2K8882 , Lot Number 160810075C , Exp. Date 5/30/2016 ; Service Code 2K8882 , Lot Number 160830062C , Exp. Date 6/1/2016 ; Service Code 2K8882 , Lot Number 160880071C , Exp. Date 6/6/2016 ; Service Code 2K8882 , Lot Number 160900112C , Exp. Date 6/8/2016 ; Service Code 2K8930 , Lot Number 160970150M , Exp. Date 5/7/2016 ; Service Code 2K8930 , Lot Number 160970151M , Exp. Date 5/7/2016 ; Service Code 2K8930 , Lot Number 161080317M , Exp. Date 5/18/2016 ; Service Code 2N1117 , Lot Number 160420020C , Exp. Date 5/12/2016 ; Service Code 2N1117 , Lot Number 160470032C , Exp. Date 5/17/2016 ; Service Code 2N1117 , Lot Number 160550028C , Exp. Date 5/25/2016 ; Service Code 2N1117 , Lot Number 160680029C , Exp. Date 6/7/2016 ; Service Code 2N1117 , Lot Number 160770039C , Exp. Date 6/16/2016 ; Service Code 2N1117 , Lot Number 160830043C , Exp. Date 6/22/2016 ; Service Code 2N1117 , Lot Number 160880056C , Exp. Date 6/27/2016 ; Service Code 2N1117 , Lot Number 160960026C , Exp. Date 7/5/2016 ; Service Code 2N1192 , Lot Number 160400192M , Exp. Date 5/10/2016 ; Service Code 2N1192 , Lot Number 160480196M , Exp. Date 5/18/2016 ; Service Code 2N1192 , Lot Number 160550005M , Exp. Date 5/24/2016 ; Service Code 2N1192 , Lot Number 160550118M , Exp. Date 5/25/2016 ; Service Code 2N1192 , Lot Number 160560204M , Exp. Date 5/26/2016 ; Service Code 2N1192 , Lot Number 160570006M , Exp. Date 5/26/2016 ; Service Code 2N1192 , Lot Number 160590060M , Exp. Date 5/29/2016 ; Service Code 2N1192 , Lot Number 160690038M , Exp. Date 6/7/2016 ; Service Code 2N1192 , Lot Number 160800071M , Exp. Date 6/18/2016 ; Service Code 2N1192 , Lot Number 160830047M , Exp. Date 6/21/2016 ; Service Code 2N1192 , Lot Number 160900125M , Exp. Date 6/28/2016 ; Service Code 2N1192 , Lot Number 160910122M , Exp. Date 6/29/2016 ; Service Code 2N1918 , Lot Number 160960017C , Exp. Date 5/6/2016 ; Service Code 2N1918 , Lot Number 160970017C , Exp. Date 5/7/2016 ; Service Code 3V8719 , Lot Number 160420031C , Exp. Date 5/12/2016 ; Service Code 3V8719 , Lot Number 160480039C , Exp. Date 5/18/2016 ; Service Code 3V8719 , Lot Number 160540029C , Exp. Date 5/24/2016 ; Service Code 3V8719 , Lot Number 160610038C , Exp. Date 5/31/2016 ; Service Code 3V8719 , Lot Number 160700003C , Exp. Date 6/9/2016 ; Service Code 3V8719 , Lot Number 160760033C , Exp. Date 6/15/2016 ; Service Code 3V8719 , Lot Number 160830047C , Exp. Date 6/22/2016 ; Service Code 3V8719 , Lot Number 160900111C , Exp. Date 6/29/2016 ; Service Code 3V8719 , Lot Number 160970031C , 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: 8,581 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-1365-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.