FDAClass IIJuly 27, 2016

6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl recall: Particulate Matter

6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx…

Why was 6.66 mcg/mL Fentanyl Citrate and 0.22% 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 160450146M , Exp. Date 5/14/2016 ; Lot Number 160520168M , Exp. Date 5/22/2016 ; Lot Number 160620181M , Exp. Date 6/1/2016 ; Lot Number 160760038M , Exp. Date 6/14/2016 ; Lot Number 160900172M , Exp. Date 6/29/2016 ;

Product
6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx…
Recalling firm
Pharmedium Services, LLC
Quantity
79 syringes
Distribution
Nationwide
Recall date
July 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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