6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recall: Particulate Matter
6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx…
Why was 6.66 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?
Lot Number 160480035C , Exp. Date 5/18/2016 ; Lot Number 160560026C , Exp. Date 5/26/2016 ; Lot Number 160620029C , Exp. Date 6/1/2016 ; Lot Number 160630001C , Exp. Date 6/1/2016 ; Lot Number 160810283M , Exp. Date 6/20/2016 ; Lot Number 160880013C , Exp. Date 6/27/2016 ; Lot Number 160890043C , Exp. Date 6/28/2016 ;
- Product
- 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx…
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 180 syringes
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)