5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Service Code 2H8287 , Lot Number 160390110M , Exp. Date 5/9/2016 ; Service Code 2H8287 , Lot Number 160450123M , Exp. Date 5/15/2016 ; Service Code 2H8287 , Lot Number 160470115M , Exp. Date 5/17/2016 ; Service Code 2H8287 , Lot Number 160600178M , Exp. Date 5/30/2016 ; Service Code 2H8287 , Lot Number 160750128M , Exp. Date 6/14/2016 ; Service Code 2H8287 , Lot Number 160800058M , Exp. Date 6/18/2016 ; Service Code 2H8287 , Lot Number 160820110M , Exp. Date 6/20/2016 ; Service Code 2H8287 , Lot Number 160960130M , Exp. Date 7/5/2016 ; Service Code 2H8287 , Lot Number 160970119M , Exp. Date 7/6/2016 ; Service Code 2K8287 , Lot Number 160530140M , Exp. Date 5/17/2016 ; Service Code 2K8287 , Lot Number 160630194M , Exp. Date 5/27/2016 ; Service Code 2K8287 , Lot Number 160680251M , Exp. Date 6/1/2016 ; Service Code 2K8287 , Lot Number 160760045M , Exp. Date 6/8/2016 ; Service Code 2K8287 , Lot Number 160770044M , Exp. Date 6/9/2016 ; Service Code 2K8287 , Lot Number 160770117M , Exp. Date 6/10/2016 ; Service Code 2K8287 , Lot Number 160940055M , Exp. Date 6/26/2016 ; Service Code 2K8287 , Lot Number 160960048M , Exp. Date 6/28/2016 ; Service Code 2K8811 , Lot Number 160490167M , Exp. Date 5/9/2016 ; Service Code 2K8811 , Lot Number 160530310M , Exp. Date 5/14/2016 ; Service Code 2K8811 , Lot Number 160600078M , Exp. Date 5/20/2016 ; Service Code 2K8811 , Lot Number 160630029M , Exp. Date 5/23/2016 ; Service Code 2K8811 , Lot Number 160670255M , Exp. Date 5/28/2016 ; Service Code 2K8811 , Lot Number 160750239M , Exp. Date 6/5/2016 ; Service Code 2K8811 , Lot Number 160810296M , Exp. Date 6/11/2016 ; Service Code 2K8811 , Lot Number 160950247M , Exp. Date 6/25/2016 ; Service Code 2K8873 , Lot Number 160680043C , Exp. Date 5/29/2016 ; Service Code 2K8873 , Lot Number 160840036C , Exp. Date 6/14/2016 ; Service Code 2K8873 , Lot Number 160870015C , Exp. Date 6/17/2016 ; Service Code 2K8873 , Lot Number 160960052C , Exp. Date 6/26/2016 ;
  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:

5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Product Codes/Lot Numbers:

Service Code 2H8287 , Lot Number 160390110M , Exp. Date 5/9/2016 ; Service Code 2H8287 , Lot Number 160450123M , Exp. Date 5/15/2016 ; Service Code 2H8287 , Lot Number 160470115M , Exp. Date 5/17/2016 ; Service Code 2H8287 , Lot Number 160600178M , Exp. Date 5/30/2016 ; Service Code 2H8287 , Lot Number 160750128M , Exp. Date 6/14/2016 ; Service Code 2H8287 , Lot Number 160800058M , Exp. Date 6/18/2016 ; Service Code 2H8287 , Lot Number 160820110M , Exp. Date 6/20/2016 ; Service Code 2H8287 , Lot Number 160960130M , Exp. Date 7/5/2016 ; Service Code 2H8287 , Lot Number 160970119M , Exp. Date 7/6/2016 ; Service Code 2K8287 , Lot Number 160530140M , Exp. Date 5/17/2016 ; Service Code 2K8287 , Lot Number 160630194M , Exp. Date 5/27/2016 ; Service Code 2K8287 , Lot Number 160680251M , Exp. Date 6/1/2016 ; Service Code 2K8287 , Lot Number 160760045M , Exp. Date 6/8/2016 ; Service Code 2K8287 , Lot Number 160770044M , Exp. Date 6/9/2016 ; Service Code 2K8287 , Lot Number 160770117M , Exp. Date 6/10/2016 ; Service Code 2K8287 , Lot Number 160940055M , Exp. Date 6/26/2016 ; Service Code 2K8287 , Lot Number 160960048M , Exp. Date 6/28/2016 ; Service Code 2K8811 , Lot Number 160490167M , Exp. Date 5/9/2016 ; Service Code 2K8811 , Lot Number 160530310M , Exp. Date 5/14/2016 ; Service Code 2K8811 , Lot Number 160600078M , Exp. Date 5/20/2016 ; Service Code 2K8811 , Lot Number 160630029M , Exp. Date 5/23/2016 ; Service Code 2K8811 , Lot Number 160670255M , Exp. Date 5/28/2016 ; Service Code 2K8811 , Lot Number 160750239M , Exp. Date 6/5/2016 ; Service Code 2K8811 , Lot Number 160810296M , Exp. Date 6/11/2016 ; Service Code 2K8811 , Lot Number 160950247M , Exp. Date 6/25/2016 ; Service Code 2K8873 , Lot Number 160680043C , Exp. Date 5/29/2016 ; Service Code 2K8873 , Lot Number 160840036C , Exp. Date 6/14/2016 ; Service Code 2K8873 , Lot Number 160870015C , Exp. Date 6/17/2016 ; Service Code 2K8873 , Lot Number 160960052C , Exp. Date 6/26/2016 ;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1424-2016

Related Recalls