0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl recall: Particulate Matter
0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette…
Why was 0.5 mcg/mL Sufentanil Citrate and 0.1% 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 160960175M; Exp. Date 5/6/2016 Lot Number 160970036M; Exp. Date 5/7/2016 Lot Number 161080071M; Exp. Date 5/18/2016
- Product
- 0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette…
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 325 Medical Cassettes
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)