FDAClass IIJuly 27, 2016

10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl recall: Particulate Matter

10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx…

Why was 10 mcg/mL Fentanyl Citrate and 0.2% 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 160380150M , Exp. Date 5/7/2016 ; Lot Number 160420180M , Exp. Date 5/11/2016 ; Lot Number 160450106M , Exp. Date 5/14/2016 ; Lot Number 160480109M , Exp. Date 5/17/2016 ; Lot Number 160660210M , Exp. Date 6/5/2016 ; Lot Number 160700121M , Exp. Date 6/8/2016 ; Lot Number 160770215M , Exp. Date 6/16/2016 ; Lot Number 160820099M , Exp. Date 6/20/2016 ; Lot Number 160880167M , Exp. Date 6/26/2016 ; Lot Number 161080045M , Exp. Date 7/16/2016 ;

Product
10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx…
Recalling firm
Pharmedium Services, LLC
Quantity
740 BD syringes
Distribution
Nationwide
Recall date
July 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls