FDAClass IIJuly 27, 2016

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

5 mcg/mL HYDROmorphone HCl 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 HYDROmorphone HCl 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 2H8477 , Lot Number 160400137M , Exp. Date 5/10/2016 ; Service Code 2H8477 , Lot Number 160450131M , Exp. Date 5/15/2016 ; Service Code 2H8477 , Lot Number 160470138M , Exp. Date 5/17/2016 ; Service Code 2H8477 , Lot Number 160480132M , Exp. Date 5/18/2016 ; Service Code 2H8477 , Lot Number 160550129M , Exp. Date 5/25/2016 ; Service Code 2H8477 , Lot Number 160610059M , Exp. Date 5/30/2016 ; Service Code 2H8477 , Lot Number 160620029M , Exp. Date 5/31/2016 ; Service Code 2H8477 , Lot Number 160680044M , Exp. Date 6/6/2016 ; Service Code 2H8477 , Lot Number 160750038M , Exp. Date 6/13/2016 ; Service Code 2H8477 , Lot Number 160760128M , Exp. Date 6/14/2016 ; Service Code 2H8477 , Lot Number 160820118M , Exp. Date 6/21/2016 ; Service Code 2H8477 , Lot Number 160830037M , Exp. Date 6/22/2016 ; Service Code 2H8477 , Lot Number 160890044M , Exp. Date 6/27/2016 ; Service Code 2H8477 , Lot Number 160900040M , Exp. Date 6/28/2016 ; Service Code 2H8477 , Lot Number 160960037M , Exp. Date 7/4/2016 ; Service Code 2H8477 , Lot Number 160970136M , Exp. Date 7/6/2016 ; Service Code 2K8477 , Lot Number 160520174M , Exp. Date 5/22/2016 ; Service Code 2K8477 , Lot Number 160890053M , Exp. Date 6/27/2016 ; Service Code 2K8477 , Lot Number 160940139M , Exp. Date 7/3/2016 ;

Product
5 mcg/mL HYDROmorphone HCl 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
445 bags
Distribution
Nationwide
Recall date
July 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls