10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl recall: Particulate Matter
10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8908, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-908-02 ,
Why was 10 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 2K8482 , Lot Number 160400113M , Exp. Date 5/10/2016 ; Service Code 2K8482 , Lot Number 160460097M , Exp. Date 5/16/2016 ; Service Code 2K8482 , Lot Number 160470229M , Exp. Date 5/17/2016 ; Service Code 2K8482 , Lot Number 160530109M , Exp. Date 5/23/2016 ; Service Code 2K8482 , Lot Number 160630133M , Exp. Date 6/2/2016 ; Service Code 2K8482 , Lot Number 160670166M , Exp. Date 6/6/2016 ; Service Code 2K8482 , Lot Number 160680146M , Exp. Date 6/7/2016 ; Service Code 2K8482 , Lot Number 160750150M , Exp. Date 6/14/2016 ; Service Code 2K8482 , Lot Number 160810139M , Exp. Date 6/20/2016 ; Service Code 2K8482 , Lot Number 160910246M , Exp. Date 6/30/2016 ; Service Code 2K8482 , Lot Number 160960036C , Exp. Date 7/5/2016 ; Service Code 2K8482 , Lot Number 160970147M , Exp. Date 7/6/2016 ; Service Code 2K8482 , Lot Number 161080277M , Exp. Date 7/17/2016 ; Service Code 2K8908 , Lot Number 160940041C , Exp. Date 5/10/2016 ; Service Code 2K8908 , Lot Number 160950030C , Exp. Date 5/11/2016 ; Service Code 2T6482 , Lot Number 160560209M , Exp. Date 5/26/2016 ; Service Code 2T6482 , Lot Number 160590158M , Exp. Date 5/29/2016 ; Service Code 2T6482 , Lot Number 160750214M , Exp. Date 6/14/2016 ;
- Product
- 10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8908, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-908-02 ,
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 1,277 bags
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)