Recalls / Class II

Class IID-1426-2016

Product

5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Affected lot / code info: Service Code 2H8139 , Lot Number 160420171M , Exp. Date 5/12/2016 ; Service Code 2H8139 , Lot Number 160460111M , Exp. Date 5/16/2016 ; Service Code 2H8139 , Lot Number 160490001M , Exp. Date 5/18/2016 ; Service Code 2H8139 , Lot Number 160530289M , Exp. Date 5/23/2016 ; Service Code 2H8139 , Lot Number 160560215M , Exp. Date 5/26/2016 ; Service Code 2H8139 , Lot Number 160590055M , Exp. Date 5/29/2016 ; Service Code 2H8139 , Lot Number 160600232M , Exp. Date 5/30/2016 ; Service Code 2H8139 , Lot Number 160610189M , Exp. Date 5/31/2016 ; Service Code 2H8139 , Lot Number 160670159M , Exp. Date 6/6/2016 ; Service Code 2H8139 , Lot Number 160740151M , Exp. Date 6/13/2016 ; Service Code 2H8139 , Lot Number 160770172M , Exp. Date 6/16/2016 ; Service Code 2H8139 , Lot Number 160800069M , Exp. Date 6/18/2016 ; Service Code 2H8139 , Lot Number 160810208M , Exp. Date 6/20/2016 ; Service Code 2H8139 , Lot Number 160900168M , Exp. Date 6/29/2016 ; Service Code 2H8139 , Lot Number 160960158M , Exp. Date 7/5/2016 ; Service Code 2H8139 , Lot Number 161080229M , Exp. Date 7/17/2016 ; Service Code 2H8140 , Lot Number 160450212M , Exp. Date 5/11/2016 ; Service Code 2H8140 , Lot Number 160550237M , Exp. Date 5/21/2016 ; Service Code 2H8140 , Lot Number 160660222M , Exp. Date 6/1/2016 ; Service Code 2H8140 , Lot Number 160670248M , Exp. Date 6/2/2016 ; Service Code 2H8140 , Lot Number 160700215M , Exp. Date 6/5/2016 ; Service Code 2H8140 , Lot Number 160870227M , Exp. Date 6/22/2016 ; Service Code 2H8140 , Lot Number 160880150M , Exp. Date 6/23/2016 ; Service Code 2H8140 , Lot Number 160940208M , Exp. Date 6/29/2016 ; Service Code 2H8140 , Lot Number 161080214M , Exp. Date 7/13/2016 ; Service Code 2K8139 , Lot Number 160450047M , Exp. Date 5/9/2016 ; Service Code 2K8139 , Lot Number 160590188M , Exp. Date 5/23/2016 ; Service Code 2K8139 , Lot Number 160610248M , Exp. Date 5/25/2016 ; Service Code 2K8139 , Lot Number 160730263M , Exp. Date 6/6/2016 ; Service Code 2K8139 , Lot Number 160770133M , Exp. Date 6/10/2016 ; Service Code 2K8139 , Lot Number 160820143M , Exp. Date 6/15/2016 ; Service Code 2K8139 , Lot Number 160880151M , Exp. Date 6/21/2016 ; Service Code 2K8139 , Lot Number 160910235M , Exp. Date 6/24/2016 ; Service Code 2K8247 , Lot Number 160400202M , Exp. Date 5/10/2016 ; Service Code 2K8247 , Lot Number 160460151M , Exp. Date 5/16/2016 ; Service Code 2K8247 , Lot Number 160470188M , Exp. Date 5/17/2016 ; Service Code 2K8247 , Lot Number 160590141M , Exp. Date 5/29/2016 ; Service Code 2K8247 , Lot Number 160620192M , Exp. Date 6/1/2016 ; Service Code 2K8247 , Lot Number 160700158M , Exp. Date 6/9/2016 ; Service Code 2K8247 , Lot Number 160820178M , Exp. Date 6/21/2016 ; Service Code 2K8247 , Lot Number 160840216M , Exp. Date 6/23/2016 ; Service Code 2K8247 , Lot Number 160910142M , Exp. Date 6/30/2016 ; Service Code 2K8247 , Lot Number 160940212M , Exp. Date 7/3/2016 ; Service Code 2K8247 , Lot Number 161080223M , Exp. Date 7/17/2016 ; Service Code 2K8813 , Lot Number 160450175M , Exp. Date 5/6/2016 ; Service Code 2K8813 , Lot Number 160460213M , Exp. Date 5/7/2016 ; Service Code 2K8813 , Lot Number 160480240M , Exp. Date 5/9/2016 ; Service Code 2K8813 , Lot Number 160520185M , Exp. Date 5/13/2016 ; Service Code 2K8813 , Lot Number 160560083M , Exp. Date 5/16/2016 ; Service Code 2K8813 , Lot Number 160630156M , Exp. Date 5/24/2016 ; Service Code 2K8813 , Lot Number 160700166M , Exp. Date 5/31/2016 ; Service Code 2K8813 , Lot Number 160770183M , Exp. Date 6/7/2016 ; Service Code 2K8813 , Lot Number 160830180M , Exp. Date 6/13/2016 ; Service Code 2K8813 , Lot Number 160910180M , Exp. Date 6/21/2016 ; Service Code 2K8875 , Lot Number 160660143M , Exp. Date 5/27/2016 ; Service Code 2K8875 , Lot Number 160770127M , Exp. Date 6/7/2016 ; Service Code 2K8875 , Lot Number 160940123M , Exp. Date 6/24/2016 ; Service Code 2K8876 , Lot Number 160490225M , Exp. Date 5/10/2016 ; Service Code 2K8876 , Lot Number 160540244M , Exp. Date 5/15/2016 ; Service Code 2K8876 , Lot Number 160540245M , Exp. Date 5/15/2016 ; Service Code 2K8876 , Lot Number 160630129M , Exp. Date 5/24/2016 ; Service Code 2K8876 , Lot Number 160700161M , Exp. Date 5/31/2016 ; Service Code 2K8876 , Lot Number 160770137M , Exp. Date 6/7/2016 ; Service Code 2K8876 , Lot Number 160810190M , Exp. Date 6/11/2016 ; Service Code 2K8876 , Lot Number 160830187M , Exp. Date 6/13/2016 ; Service Code 2K8876 , Lot Number 160830188M , Exp. Date 6/13/2016 ; Service Code 2K8876 , Lot Number 160830189M , Exp. Date 6/13/2016 ; Service Code 2K8876 , Lot Number 160910229M , Exp. Date 6/21/2016 ; Service Code 2K8876 , Lot Number 161080079M , Exp. Date 7/7/2016 ; Service Code 2T6140 , Lot Number 160380106M , Exp. Date 5/7/2016 ; Service Code 2T6140 , Lot Number 160460193M , Exp. Date 5/16/2016 ; Service Code 2T6140 , Lot Number 160520182M , Exp. Date 5/22/2016 ; Service Code 2T6140 , Lot Number 160540193M , Exp. Date 5/23/2016 ; Service Code 2T6140 , Lot Number 160560094M , Exp. Date 5/25/2016 ; Service Code 2T6140 , Lot Number 160600050M , Exp. Date 5/29/2016 ; Service Code 2T6140 , Lot Number 160660153M , Exp. Date 6/5/2016 ; Service Code 2T6140 , Lot Number 160950214M , Exp. Date 7/4/2016 ; Service Code 2T6222 , Lot Number 160420160M , Exp. Date 5/11/2016 ; Service Code 2T8875 , Lot Number 160960145M , Exp. Date 5/6/2016 ; Service Code 2T8876 , Lot Number 160960131M , Exp. Date 5/6/2016 ; Service Code 4J8139 , Lot Number 160460122M , Exp. Date 5/10/2016 ; Service Code 4J8139 , Lot Number 160680045M , Exp. Date 5/31/2016 ; Service Code 4J8139 , Lot Number 160810171M , Exp. Date 6/14/2016 ; Service Code 4J8139 , Lot Number 160950057M , 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: 3,927 syringes
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-1426-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.