FDAClass IIJuly 27, 2016

10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recall: Particulate Matter

10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code…

Why was 10 mcg/mL Fentanyl Citrate and 0.125% 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 2T6014 , Lot Number 160390220M , Exp. Date 5/9/2016 ; Service Code 2T6014 , Lot Number 160700029M , Exp. Date 6/8/2016 ; Service Code 2T6636 , Lot Number 160380145M , Exp. Date 5/7/2016 ; Service Code 2T6636 , Lot Number 160390003M , Exp. Date 5/8/2016 ; Service Code 2T6636 , Lot Number 160460177M , Exp. Date 5/15/2016 ; Service Code 2T6636 , Lot Number 160490165M , Exp. Date 5/18/2016 ; Service Code 2T6636 , Lot Number 160550201M , Exp. Date 5/24/2016 ; Service Code 2T6636 , Lot Number 160670237M , Exp. Date 6/6/2016 ; Service Code 2T6636 , Lot Number 160680008M , Exp. Date 6/6/2016 ; Service Code 2T6636 , Lot Number 160700023M , Exp. Date 6/8/2016 ; Service Code 2T6636 , Lot Number 160710003M , Exp. Date 6/9/2016 ; Service Code 2T6636 , Lot Number 160740258M , Exp. Date 6/13/2016 ;

Product
10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code…
Recalling firm
Pharmedium Services, LLC
Quantity
600 Monoject Syringes
Distribution
Nationwide
Recall date
July 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls