5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl recall: Particulate Matter
5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 ,
Why was 5 mcg/mL Fentanyl Citrate and 0.05% 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 2H8256 , Lot Number 160410124M , Exp. Date 5/11/2016 ; Service Code 2H8256 , Lot Number 160560146M , Exp. Date 5/26/2016 ; Service Code 2H8256 , Lot Number 160590041M , Exp. Date 5/29/2016 ; Service Code 2H8256 , Lot Number 160690131M , Exp. Date 6/8/2016 ; Service Code 2H8256 , Lot Number 160900157M , Exp. Date 6/29/2016 ; Service Code 2K8254 , Lot Number 160390176M , Exp. Date 5/9/2016 ; Service Code 2K8254 , Lot Number 160410129M , Exp. Date 5/11/2016 ; Service Code 2K8254 , Lot Number 160460130M , Exp. Date 5/16/2016 ; Service Code 2K8254 , Lot Number 160530293M , Exp. Date 5/23/2016 ; Service Code 2K8254 , Lot Number 160590075M , Exp. Date 5/29/2016 ; Service Code 2K8254 , Lot Number 160600187M , Exp. Date 5/30/2016 ; Service Code 2K8254 , Lot Number 160610002M , Exp. Date 5/30/2016 ; Service Code 2K8254 , Lot Number 160680155M , Exp. Date 6/6/2016 ; Service Code 2K8254 , Lot Number 160760125M , Exp. Date 6/14/2016 ; Service Code 2K8254 , Lot Number 160880192M , Exp. Date 6/27/2016 ; Service Code 2K8254 , Lot Number 160890178M , Exp. Date 6/28/2016 ; Service Code 2K8256 , Lot Number 160480195M , Exp. Date 5/12/2016 ; Service Code 2K8256 , Lot Number 160530189M , Exp. Date 5/17/2016 ; Service Code 2K8256 , Lot Number 160560081M , Exp. Date 5/19/2016 ; Service Code 2K8256 , Lot Number 160590069M , Exp. Date 5/23/2016 ; Service Code 2K8256 , Lot Number 160660151M , Exp. Date 5/30/2016 ; Service Code 2K8256 , Lot Number 160680250M , Exp. Date 6/1/2016 ; Service Code 2K8256 , Lot Number 160880025M , Exp. Date 6/20/2016 ; Service Code 2K8256 , Lot Number 160950047M , Exp. Date 6/27/2016 ;
- Product
- 5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 ,
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 655 bags
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)