20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl recall: Particulate Matter
20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette…
Why was 20 mcg/mL HYDROmorphone HCl 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 2K8158 , Lot Number 160380113M , Exp. Date 5/8/2016 ; Service Code 2K8158 , Lot Number 160410115M , Exp. Date 5/11/2016 ; Service Code 2K8158 , Lot Number 160420111M , Exp. Date 5/12/2016 ; Service Code 2K8158 , Lot Number 160450184M , Exp. Date 5/15/2016 ; Service Code 2K8158 , Lot Number 160520106M , Exp. Date 5/21/2016 ; Service Code 2K8158 , Lot Number 160530143M , Exp. Date 5/23/2016 ; Service Code 2K8158 , Lot Number 160550124M , Exp. Date 5/25/2016 ; Service Code 2K8158 , Lot Number 160560211M , Exp. Date 5/26/2016 ; Service Code 2K8158 , Lot Number 160600195M , Exp. Date 5/30/2016 ; Service Code 2K8158 , Lot Number 160620137M , Exp. Date 6/1/2016 ; Service Code 2K8158 , Lot Number 160690124M , Exp. Date 6/7/2016 ; Service Code 2K8158 , Lot Number 160730219M , Exp. Date 6/12/2016 ; Service Code 2K8158 , Lot Number 160740084C , Exp. Date 6/14/2016 ; Service Code 2K8158 , Lot Number 160770123M , Exp. Date 6/16/2016 ; Service Code 2K8158 , Lot Number 160840027M , Exp. Date 6/22/2016 ; Service Code 2K8158 , Lot Number 160870228M , Exp. Date 6/26/2016 ; Service Code 2K8158 , Lot Number 160910212M , Exp. Date 6/30/2016 ; Service Code 2K8158 , Lot Number 161080220M , Exp. Date 7/17/2016 ; Service Code 2K8495 , Lot Number 160420155M , Exp. Date 5/12/2016 ; Service Code 2K8495 , Lot Number 160490122M , Exp. Date 5/19/2016 ; Service Code 2K8913 , Lot Number 160940019C , Exp. Date 5/10/2016 ; Service Code 2K8913 , Lot Number 160960022C , Exp. Date 5/12/2016 ; Service Code 2K8913 , Lot Number 160970021C , Exp. Date 5/13/2016 ; Service Code 2K8947 , Lot Number 160970025C , Exp. Date 5/17/2016 ; Service Code 2K8986 , Lot Number 160910040M , Exp. Date 5/11/2016 ; Service Code 2T6622 , Lot Number 160950152M , Exp. Date 5/10/2016 ; Service Code 2K8495 , Lot Number 160520175M , Exp. Date 5/22/2016 ; Service Code 2K8495 , Lot Number 160530128M , Exp. Date 5/23/2016 ; Service Code 2K8495 , Lot Number 160540117M , Exp. Date 5/24/2016 ; Service Code 2K8495 , Lot Number 160550130M , Exp. Date 5/25/2016 ; Service Code 2K8495 , Lot Number 160560135M , Exp. Date 5/26/2016 ; Service Code 2K8495 , Lot Number 160610198M , Exp. Date 5/31/2016 ; Service Code 2K8495 , Lot Number 160740237M , Exp. Date 6/13/2016 ; Service Code 2K8495 , Lot Number 160750177M , Exp. Date 6/14/2016 ; Service Code 2K8495 , Lot Number 160760001M , Exp. Date 6/14/2016 ; Service Code 2K8495 , Lot Number 160820228M , Exp. Date 6/21/2016 ; Service Code 2K8495 , Lot Number 160890173M , Exp. Date 6/28/2016 ;
- Product
- 20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette…
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 555 Medical Cassettes
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)