3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl recall: Particulate Matter
3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code…
Why was 3.5 mcg/mL Fentanyl Citrate and 0.0625%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 160390336M , Exp. Date 5/9/2016 ; Lot Number 160530318M , Exp. Date 5/23/2016 ; Lot Number 160600347M , Exp. Date 5/30/2016 ; Lot Number 160750243M , Exp. Date 6/14/2016 ; Lot Number 160760164M , Exp. Date 6/14/2016 ; Lot Number 160830228M , Exp. Date 6/22/2016 ; Lot Number 160890224M , Exp. Date 6/28/2016 ; Lot Number 160960242M , Exp. Date 7/5/2016 ; Lot Number 160970140M , Exp. Date 7/6/2016 ;
- Product
- 3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code…
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 1,015 bags
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)