2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl recall: Particulate Matter
2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8095, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-095-50 ,
Why was 2 mcg/mL Fentanyl Citrate and 0.06% 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 160390213M , Exp. Date 5/9/2016 ; Lot Number 160420162M , Exp. Date 5/12/2016 ; Lot Number 160480197M , Exp. Date 5/18/2016 ; Lot Number 160600057M , Exp. Date 5/29/2016 ; Lot Number 161080145M , Exp. Date 7/17/2016 ;
- Product
- 2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8095, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-095-50 ,
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 60 bags
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)