FDAClass IIJuly 27, 2016

5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl recall: Particulate Matter

5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code…

Why was 5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl recalled?

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Service Code 2H8287 , Lot Number 160390110M , Exp. Date 5/9/2016 ; Service Code 2H8287 , Lot Number 160450123M , Exp. Date 5/15/2016 ; Service Code 2H8287 , Lot Number 160470115M , Exp. Date 5/17/2016 ; Service Code 2H8287 , Lot Number 160600178M , Exp. Date 5/30/2016 ; Service Code 2H8287 , Lot Number 160750128M , Exp. Date 6/14/2016 ; Service Code 2H8287 , Lot Number 160800058M , Exp. Date 6/18/2016 ; Service Code 2H8287 , Lot Number 160820110M , Exp. Date 6/20/2016 ; Service Code 2H8287 , Lot Number 160960130M , Exp. Date 7/5/2016 ; Service Code 2H8287 , Lot Number 160970119M , Exp. Date 7/6/2016 ; Service Code 2K8287 , Lot Number 160530140M , Exp. Date 5/17/2016 ; Service Code 2K8287 , Lot Number 160630194M , Exp. Date 5/27/2016 ; Service Code 2K8287 , Lot Number 160680251M , Exp. Date 6/1/2016 ; Service Code 2K8287 , Lot Number 160760045M , Exp. Date 6/8/2016 ; Service Code 2K8287 , Lot Number 160770044M , Exp. Date 6/9/2016 ; Service Code 2K8287 , Lot Number 160770117M , Exp. Date 6/10/2016 ; Service Code 2K8287 , Lot Number 160940055M , Exp. Date 6/26/2016 ; Service Code 2K8287 , Lot Number 160960048M , Exp. Date 6/28/2016 ; Service Code 2K8811 , Lot Number 160490167M , Exp. Date 5/9/2016 ; Service Code 2K8811 , Lot Number 160530310M , Exp. Date 5/14/2016 ; Service Code 2K8811 , Lot Number 160600078M , Exp. Date 5/20/2016 ; Service Code 2K8811 , Lot Number 160630029M , Exp. Date 5/23/2016 ; Service Code 2K8811 , Lot Number 160670255M , Exp. Date 5/28/2016 ; Service Code 2K8811 , Lot Number 160750239M , Exp. Date 6/5/2016 ; Service Code 2K8811 , Lot Number 160810296M , Exp. Date 6/11/2016 ; Service Code 2K8811 , Lot Number 160950247M , Exp. Date 6/25/2016 ; Service Code 2K8873 , Lot Number 160680043C , Exp. Date 5/29/2016 ; Service Code 2K8873 , Lot Number 160840036C , Exp. Date 6/14/2016 ; Service Code 2K8873 , Lot Number 160870015C , Exp. Date 6/17/2016 ; Service Code 2K8873 , Lot Number 160960052C , Exp. Date 6/26/2016 ;

Product
5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code…
Recalling firm
Pharmedium Services, LLC
Quantity
562 bags
Distribution
Nationwide
Recall date
July 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls