Recalls / Class II

Class IID-1364-2016

Product

0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8272(NDC 61553-272-52), 100 ml in 100 ml Yellow Smiths Medical Cassette Service Code 2K8941 (NDC 61553-941-48), 250 ml in 250 ml Baxter Intravia Bag (W/O Additive Cap) Service Code 3V8716, (NDC 61553-716-17), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141,

Affected lot / code info: Service Code 2K8195 , Lot Number 160390084M , Exp. Date 5/9/2016 ; Service Code 2K8195 , Lot Number 160530298M , Exp. Date 5/23/2016 ; Service Code 2K8195 , Lot Number 160540203M , Exp. Date 5/24/2016 ; Service Code 2K8195 , Lot Number 160550182M , Exp. Date 5/25/2016 ; Service Code 2K8195 , Lot Number 160590153M , Exp. Date 5/29/2016 ; Service Code 2K8195 , Lot Number 160660150M , Exp. Date 6/5/2016 ; Service Code 2K8195 , Lot Number 160740115M , Exp. Date 6/12/2016 ; Service Code 2K8195 , Lot Number 160810295M , Exp. Date 6/20/2016 ; Service Code 2K8195 , Lot Number 160820217M , Exp. Date 6/21/2016 ; Service Code 2K8195 , Lot Number 160830164M , Exp. Date 6/21/2016 ; Service Code 2K8195 , Lot Number 160950236M , Exp. Date 7/4/2016 ; Service Code 2K8195 , Lot Number 160970203M , Exp. Date 7/6/2016 ; Service Code 2H8266 , Lot Number 160410177M , Exp. Date 5/11/2016 ; Service Code 2H8266 , Lot Number 160600056M , Exp. Date 5/29/2016 ; Service Code 2H8266 , Lot Number 160740185M , Exp. Date 6/13/2016 ; Service Code 2H8266 , Lot Number 160830175M , Exp. Date 6/22/2016 ; Service Code 2H8266 , Lot Number 160950218M , Exp. Date 7/4/2016 ; Service Code 2H8272 , Lot Number 160450150M , Exp. Date 5/15/2016 ; Service Code 2H8272 , Lot Number 160600070M , Exp. Date 5/29/2016 ; Service Code 2H8272 , Lot Number 160900043M , Exp. Date 6/28/2016 ; Service Code 2K8115 , Lot Number 160530135M , Exp. Date 5/23/2016 ; Service Code 2K8115 , Lot Number 160740158M , Exp. Date 6/13/2016 ; Service Code 2K8115 , Lot Number 160940047M , Exp. Date 7/2/2016 ; Service Code 2K8115 , Lot Number 160950158M , Exp. Date 7/4/2016 ; Service Code 2K8216 , Lot Number 160390353M , Exp. Date 5/9/2016 ; Service Code 2K8216 , Lot Number 160470237M , Exp. Date 5/17/2016 ; Service Code 2K8216 , Lot Number 160480276M , Exp. Date 5/18/2016 ; Service Code 2K8216 , Lot Number 160540026M , Exp. Date 5/24/2016 ; Service Code 2K8216 , Lot Number 160610271M , Exp. Date 5/31/2016 ; Service Code 2K8216 , Lot Number 160730105M , Exp. Date 6/12/2016 ; Service Code 2K8216 , Lot Number 160820198M , Exp. Date 6/21/2016 ; Service Code 2K8216 , Lot Number 160890280M , Exp. Date 6/28/2016 ; Service Code 2K8216 , Lot Number 160950038M , Exp. Date 7/4/2016 ; Service Code 2K8216 , Lot Number 161080329M , Exp. Date 7/17/2016 ; Service Code 2K8265 , Lot Number 160390177M , Exp. Date 5/9/2016 ; Service Code 2K8265 , Lot Number 160460174M , Exp. Date 5/16/2016 ; Service Code 2K8265 , Lot Number 160670198M , Exp. Date 6/6/2016 ; Service Code 2K8265 , Lot Number 160700004M , Exp. Date 6/8/2016 ; Service Code 2K8941 , Lot Number 160660352M , Exp. Date 5/15/2016 ; Service Code 2K8941 , Lot Number 160670183M , Exp. Date 5/16/2016 ; Service Code 2K8941 , Lot Number 160680195M , Exp. Date 5/17/2016 ; Service Code 2K8941 , Lot Number 160700129M , Exp. Date 5/18/2016 ; Service Code 2K8941 , Lot Number 160810184M , Exp. Date 5/30/2016 ; Service Code 2K8941 , Lot Number 160880172M , Exp. Date 6/5/2016 ; Service Code 2K8941 , Lot Number 160950159M , Exp. Date 6/13/2016 ; Service Code 2K8981 , Lot Number 160810255M , Exp. Date 5/30/2016 ; Service Code 2K8981 , Lot Number 160820101M , Exp. Date 5/30/2016 ; Service Code 2K8981 , Lot Number 160870158M , Exp. Date 6/5/2016 ; Service Code 2K8981 , Lot Number 160940056M , Exp. Date 6/12/2016 ; Service Code 2K9195 , Lot Number 160480120M , Exp. Date 5/18/2016 ; Service Code 2K9195 , Lot Number 160560132M , Exp. Date 5/26/2016 ; Service Code 2K9195 , Lot Number 160630008M , Exp. Date 6/1/2016 ; Service Code 2K9195 , Lot Number 160690115M , Exp. Date 6/8/2016 ; Service Code 2K9195 , Lot Number 160800136M , Exp. Date 6/19/2016 ; Service Code 2K9195 , Lot Number 160960023M , Exp. Date 7/5/2016 ; Service Code 2N1216 , Lot Number 160410171M , Exp. Date 5/11/2016 ; Service Code 2N1216 , Lot Number 160460136M , Exp. Date 5/16/2016 ; Service Code 2N1216 , Lot Number 160550200M , Exp. Date 5/25/2016 ; Service Code 2N1216 , Lot Number 160560092M , Exp. Date 5/25/2016 ; Service Code 2N1216 , Lot Number 160590070M , Exp. Date 5/29/2016 ; Service Code 2N1216 , Lot Number 160820128M , Exp. Date 6/21/2016 ; Service Code 2N1216 , Lot Number 160870064M , Exp. Date 6/25/2016 ; Service Code 2N1216 , Lot Number 160910029M , Exp. Date 6/29/2016 ; Service Code 2N1216 , Lot Number 160940046M , Exp. Date 7/2/2016 ; Service Code 2T8929 , Lot Number 160380099M , Exp. Date 5/7/2016 ; Service Code 2T8929 , Lot Number 160450107M , Exp. Date 5/14/2016 ; Service Code 2T8929 , Lot Number 160520098M , Exp. Date 5/21/2016 ; Service Code 2T8929 , Lot Number 160670039C , Exp. Date 6/6/2016 ; Service Code 2T8929 , Lot Number 160730024C , Exp. Date 6/12/2016 ; Service Code 2T8929 , Lot Number 160870018C , Exp. Date 6/25/2016 ; Service Code 2T8981 , Lot Number 160380016C , Exp. Date 5/8/2016 ; Service Code 2T8981 , Lot Number 160450021C , Exp. Date 5/15/2016 ; Service Code 2T8981 , Lot Number 160590008C , Exp. Date 5/29/2016 ; Service Code 2T8981 , Lot Number 160800031C , Exp. Date 6/19/2016 ; Service Code 2T8981 , Lot Number 160870012C , Exp. Date 6/26/2016 ; Service Code 3V8716 , Lot Number 160480036C , Exp. Date 5/18/2016 ; Service Code 3V8716 , Lot Number 160680034C , Exp. Date 6/7/2016 ; Service Code 3V8716 , Lot Number 160810069C , Exp. Date 6/20/2016 ; Service Code 3V8716 , Lot Number 160820048C , Exp. Date 6/21/2016 ; Service Code 3V8716 , Lot Number 160950060C , Exp. Date 7/4/2016 ;

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: 4,081 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-1364-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.