20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Service Code 2K8157 , Lot Number 160420116M , Exp. Date 5/12/2016 ; Service Code 2K8157 , Lot Number 160540135M , Exp. Date 5/24/2016 ; Service Code 2K8157 , Lot Number 160630121M , Exp. Date 6/2/2016 ; Service Code 2K8157 , Lot Number 160730218M , Exp. Date 6/12/2016 ; Service Code 2K8157 , Lot Number 160760126M , Exp. Date 6/14/2016 ; Service Code 2K8157 , Lot Number 160770152M , Exp. Date 6/16/2016 ; Service Code 2K8157 , Lot Number 160810169M , Exp. Date 6/20/2016 ; Service Code 2K8157 , Lot Number 160840206M , Exp. Date 6/23/2016 ; Service Code 2K8157 , Lot Number 160940210M , Exp. Date 7/3/2016 ; Service Code 2T6620 , Lot Number 160900133M , Exp. Date 5/6/2016 ;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Pharmedium Services, LLC
Reason for Recall:
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12

Product Codes/Lot Numbers:

Service Code 2K8157 , Lot Number 160420116M , Exp. Date 5/12/2016 ; Service Code 2K8157 , Lot Number 160540135M , Exp. Date 5/24/2016 ; Service Code 2K8157 , Lot Number 160630121M , Exp. Date 6/2/2016 ; Service Code 2K8157 , Lot Number 160730218M , Exp. Date 6/12/2016 ; Service Code 2K8157 , Lot Number 160760126M , Exp. Date 6/14/2016 ; Service Code 2K8157 , Lot Number 160770152M , Exp. Date 6/16/2016 ; Service Code 2K8157 , Lot Number 160810169M , Exp. Date 6/20/2016 ; Service Code 2K8157 , Lot Number 160840206M , Exp. Date 6/23/2016 ; Service Code 2K8157 , Lot Number 160940210M , Exp. Date 7/3/2016 ; Service Code 2T6620 , Lot Number 160900133M , Exp. Date 5/6/2016 ;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1409-2016

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