FDAClass IIJuly 27, 2016

2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl recall: Particulate Matter

2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code…

Why was 2 mcg/mL Fentanyl Citrate and 0.16% 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?

Lot Number 160380168M , Exp. Date 5/8/2016 ; Lot Number 160410137M , Exp. Date 5/11/2016 ; Lot Number 160460150M , Exp. Date 5/16/2016 ; Lot Number 160530279M , Exp. Date 5/23/2016 ; Lot Number 160590185M , Exp. Date 5/29/2016 ; Lot Number 160630160M , Exp. Date 6/2/2016 ; Lot Number 160680179M , Exp. Date 6/7/2016 ; Lot Number 160730238M , Exp. Date 6/12/2016 ; Lot Number 160840215M , Exp. Date 6/23/2016 ; Lot Number 160880193M , Exp. Date 6/27/2016 ; Lot Number 160890187M , Exp. Date 6/28/2016 ;

Product
2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code…
Recalling firm
Pharmedium Services, LLC
Quantity
940 bags
Distribution
Nationwide
Recall date
July 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls