2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recall: Particulate Matter
2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, flow…
Why was 2.5 mcg/mL Fentanyl Citrate and 0.125% 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 2K8210 , Lot Number 160390175M , Exp. Date 5/9/2016 ; Service Code 2K8210 , Lot Number 160400226M , Exp. Date 5/10/2016 ; Service Code 2K8210 , Lot Number 160520170M , Exp. Date 5/22/2016 ; Service Code 2K8210 , Lot Number 160590066M , Exp. Date 5/29/2016 ; Service Code 2K8210 , Lot Number 160670046M , Exp. Date 6/5/2016 ; Service Code 2K8210 , Lot Number 160680006M , Exp. Date 6/6/2016 ; Service Code 2K8210 , Lot Number 160700027M , Exp. Date 6/8/2016 ; Service Code 2K8210 , Lot Number 160730069M , Exp. Date 6/11/2016 ; Service Code 2K8210 , Lot Number 160880217M , Exp. Date 6/27/2016 ; Service Code 2K8972 , Lot Number 160450177M , Exp. Date 5/6/2016 ; Service Code 2K8972 , Lot Number 160460196M , Exp. Date 5/7/2016 ; Service Code 2K8972 , Lot Number 160600082M , Exp. Date 5/20/2016 ; Service Code 2K8972 , Lot Number 160670061C , Exp. Date 5/28/2016 ; Service Code 2K8972 , Lot Number 160740067C , Exp. Date 6/4/2016 ; Service Code 2K8972 , Lot Number 160810085C , Exp. Date 6/11/2016 ; Service Code 2K8972 , Lot Number 160950188M , Exp. Date 6/25/2016 ;
- Product
- 2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, flow…
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 220 Medical Cassettes
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)