4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl recall: Particulate Matter
4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983…
Why was 4 mcg/mL Fentanyl Citrate and 0.1% 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 2H8267 , Lot Number 160630024M , Exp. Date 5/28/2016 ; Service Code 2K8128 , Lot Number 160490252M , Exp. Date 5/13/2016 ; Service Code 2K8128 , Lot Number 160530274M , Exp. Date 5/17/2016 ; Service Code 2K8128 , Lot Number 160600213M , Exp. Date 5/24/2016 ; Service Code 2K8128 , Lot Number 160660184M , Exp. Date 5/30/2016 ; Service Code 2K8128 , Lot Number 160730236M , Exp. Date 6/6/2016 ; Service Code 2K8128 , Lot Number 160810218M , Exp. Date 6/14/2016 ; Service Code 2K8128 , Lot Number 160820186M , Exp. Date 6/15/2016 ; Service Code 2K8128 , Lot Number 160940172M , Exp. Date 6/27/2016 ; Service Code 2K8267 , Lot Number 160450259M , Exp. Date 5/15/2016 ; Service Code 2K8267 , Lot Number 160540156M , Exp. Date 5/24/2016 ; Service Code 2K8267 , Lot Number 160600323M , Exp. Date 5/30/2016 ; Service Code 2K8267 , Lot Number 160660257M , Exp. Date 6/5/2016 ; Service Code 2K8267 , Lot Number 160730258M , Exp. Date 6/12/2016 ; Service Code 2K8267 , Lot Number 160770130M , Exp. Date 6/16/2016 ; Service Code 2K8267 , Lot Number 160840132M , Exp. Date 6/23/2016 ; Service Code 2K8267 , Lot Number 160900007M , Exp. Date 6/28/2016 ; Service Code 2K8267 , Lot Number 160970143M , Exp. Date 7/6/2016 ; Service Code 2K8267 , Lot Number 161080249M , Exp. Date 7/17/2016 ; Service Code 2K8638 , Lot Number 160410229M , Exp. Date 5/11/2016 ; Service Code 2K8638 , Lot Number 160420200M , Exp. Date 5/12/2016 ; Service Code 2K8638 , Lot Number 160460214M , Exp. Date 5/16/2016 ; Service Code 2K8638 , Lot Number 160480210M , Exp. Date 5/17/2016 ; Service Code 2K8638 , Lot Number 160490254M , Exp. Date 5/19/2016 ; Service Code 2K8638 , Lot Number 160490255M , Exp. Date 5/19/2016 ; Service Code 2K8638 , Lot Number 160520127M , Exp. Date 5/22/2016 ; Service Code 2K8638 , Lot Number 160600310M , Exp. Date 5/30/2016 ; Service Code 2K8638 , Lot Number 160630164M , Exp. Date 6/2/2016 ; Service Code 2K8638 , Lot Number 160670272M , Exp. Date 6/6/2016 ; Service Code 2K8638 , Lot Number 160750259M , Exp. Date 6/14/2016 ; Service Code 2K8638 , Lot Number 160770264M , Exp. Date 6/16/2016 ; Service Code 2K8638 , Lot Number 160840238M , Exp. Date 6/23/2016 ; Service Code 2K8638 , Lot Number 160870197M , Exp. Date 6/26/2016 ; Service Code 2K8638 , Lot Number 160950189M , Exp. Date 7/4/2016 ; Service Code 2K8983 , Lot Number 160530047C , Exp. Date 5/14/2016 ; Service Code 2K8983 , Lot Number 160740088C , Exp. Date 6/4/2016 ; Service Code 2K8983 , Lot Number 160880066C , Exp. Date 6/18/2016 ; Service Code 2K8983 , Lot Number 160970040C , Exp. Date 6/27/2016 ;
- Product
- 4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983…
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 3,828 syringes
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)