FDAClass IIJuly 27, 2016

2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl recall: Particulate Matter

2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code…

Why was 2.5 mcg/mL Fentanyl Citrate and 0.1% 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 2H8255 , Lot Number 160550161M , Exp. Date 5/11/2016 ; Service Code 2H8255 , Lot Number 160620170M , Exp. Date 5/18/2016 ; Service Code 2H8255 , Lot Number 160760132M , Exp. Date 6/1/2016 ; Service Code 2H8255 , Lot Number 160830148M , Exp. Date 6/8/2016 ; Service Code 2H8255 , Lot Number 160900158M , Exp. Date 6/15/2016 ; Service Code 2H8255 , Lot Number 160970139M , Exp. Date 6/22/2016 ; Service Code 2K8255 , Lot Number 160490046C , Exp. Date 5/13/2016 ; Service Code 2K8255 , Lot Number 160620032C , Exp. Date 5/26/2016 ; Service Code 2K8255 , Lot Number 160770046C , Exp. Date 6/10/2016 ; Service Code 2K8464 , Lot Number 160420154M , Exp. Date 5/6/2016 ; Service Code 2K8464 , Lot Number 160530249M , Exp. Date 5/17/2016 ; Service Code 2K8464 , Lot Number 160540207M , Exp. Date 5/18/2016 ; Service Code 2K8464 , Lot Number 160660045M , Exp. Date 5/29/2016 ; Service Code 2K8464 , Lot Number 160730092M , Exp. Date 6/6/2016 ; Service Code 2K8464 , Lot Number 160840137M , Exp. Date 6/17/2016 ; Service Code 2K8464 , Lot Number 160910145M , Exp. Date 6/24/2016 ; Service Code 2T8255 , Lot Number 160480271M , Exp. Date 5/9/2016 ; Service Code 2T8255 , Lot Number 160530302M , Exp. Date 5/14/2016 ; Service Code 2T8255 , Lot Number 160600047C , Exp. Date 5/21/2016 ; Service Code 2T8255 , Lot Number 160610032C , Exp. Date 5/22/2016 ; Service Code 2T8255 , Lot Number 160700030C , Exp. Date 5/30/2016 ; Service Code 2T8255 , Lot Number 160700031C , Exp. Date 5/31/2016 ; Service Code 2T8255 , Lot Number 160740060C , Exp. Date 6/4/2016 ; Service Code 2T8255 , Lot Number 160770034C , Exp. Date 6/7/2016 ; Service Code 2T8255 , Lot Number 160830059C , Exp. Date 6/13/2016 ; Service Code 2T8255 , Lot Number 160880040C , Exp. Date 6/18/2016 ; Service Code 2T8255 , Lot Number 160880041C , Exp. Date 6/18/2016 ; Service Code 2T8255 , Lot Number 160940029C , Exp. Date 6/24/2016 ; Service Code 2T8255 , Lot Number 160950051C , Exp. Date 6/25/2016 ;

Product
2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code…
Recalling firm
Pharmedium Services, LLC
Quantity
2,006 bags
Distribution
Nationwide
Recall date
July 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls