10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl recall: Particulate Matter
10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-909-02 ,
Why was 10 mcg/mL HYDROmorphone HCl 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?
Service Code 2H8481 , Lot Number 160460180M , Exp. Date 5/16/2016 ; Service Code 2H8481 , Lot Number 160540181M , Exp. Date 5/24/2016 ; Service Code 2H8481 , Lot Number 160830170M , Exp. Date 6/22/2016 ; Service Code 2K8481 , Lot Number 160380110M , Exp. Date 5/8/2016 ; Service Code 2K8481 , Lot Number 160390206M , Exp. Date 5/9/2016 ; Service Code 2K8481 , Lot Number 160400241M , Exp. Date 5/10/2016 ; Service Code 2K8481 , Lot Number 160410170M , Exp. Date 5/11/2016 ; Service Code 2K8481 , Lot Number 160450130M , Exp. Date 5/15/2016 ; Service Code 2K8481 , Lot Number 160480181M , Exp. Date 5/18/2016 ; Service Code 2K8481 , Lot Number 160520033M , Exp. Date 5/22/2016 ; Service Code 2K8481 , Lot Number 160530127M , Exp. Date 5/23/2016 ; Service Code 2K8481 , Lot Number 160540137M , Exp. Date 5/24/2016 ; Service Code 2K8481 , Lot Number 160560212M , Exp. Date 5/26/2016 ; Service Code 2K8481 , Lot Number 160600294M , Exp. Date 5/30/2016 ; Service Code 2K8481 , Lot Number 160610237M , Exp. Date 5/31/2016 ; Service Code 2K8481 , Lot Number 160630118M , Exp. Date 6/2/2016 ; Service Code 2K8481 , Lot Number 160660175M , Exp. Date 6/5/2016 ; Service Code 2K8481 , Lot Number 160670245M , Exp. Date 6/6/2016 ; Service Code 2K8481 , Lot Number 160730063M , Exp. Date 6/12/2016 ; Service Code 2K8481 , Lot Number 160770227M , Exp. Date 6/16/2016 ; Service Code 2K8481 , Lot Number 160840171M , Exp. Date 6/23/2016 ; Service Code 2K8481 , Lot Number 160870146M , Exp. Date 6/26/2016 ; Service Code 2K8481 , Lot Number 160910219M , Exp. Date 6/30/2016 ; Service Code 2K8481 , Lot Number 160940163M , Exp. Date 7/3/2016 ; Service Code 2K8481 , Lot Number 160970137M , Exp. Date 7/6/2016 ; Service Code 2K8481 , Lot Number 161080124M , Exp. Date 7/17/2016 ; Service Code 2K8909 , Lot Number 160910236M , Exp. Date 5/7/2016 ; Service Code 2K8909 , Lot Number 160950070C , Exp. Date 5/11/2016 ; Service Code 2K8909 , Lot Number 161080282M , Exp. Date 5/24/2016 ; Service Code 2K8911 , Lot Number 160970035M , Exp. Date 5/6/2016 ; Service Code 2T6481 , Lot Number 160590144M , Exp. Date 5/29/2016 ; Service Code 2T6481 , Lot Number 160610031M , Exp. Date 5/31/2016 ;
- Product
- 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-909-02 ,
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 1,234 Medical Cassettes
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)