5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl recall: Particulate Matter
5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, Service…
Why was 5 mcg/mL Fentanyl Citrate and 0.25% 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 160500008M , Exp. Date 5/10/2016 ; Lot Number 160940038C , Exp. Date 6/24/2016 ; Lot Number 160970126M , Exp. Date 6/27/2016 ; Lot Number 161080140M , Exp. Date 7/8/2016 ;
- Product
- 5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, Service…
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 45 Medical Cassettes
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)