4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC 61553-211-08), 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 2H8126 , Lot Number 161080146M , Exp. Date 7/17/2016 ; Service Code 2K8127 , Lot Number 160460115M , Exp. Date 5/10/2016 ; Service Code 2K8127 , Lot Number 160560222M , Exp. Date 5/20/2016 ; Service Code 2K8127 , Lot Number 160610209M , Exp. Date 5/25/2016 ; Service Code 2K8127 , Lot Number 160620148M , Exp. Date 5/26/2016 ; Service Code 2K8127 , Lot Number 160660062M , Exp. Date 5/29/2016 ; Service Code 2K8127 , Lot Number 160680154M , Exp. Date 6/1/2016 ; Service Code 2K8127 , Lot Number 160690126M , Exp. Date 6/2/2016 ; Service Code 2K8127 , Lot Number 160740153M , Exp. Date 6/7/2016 ; Service Code 2K8127 , Lot Number 160800064M , Exp. Date 6/12/2016 ; Service Code 2K8127 , Lot Number 160810161M , Exp. Date 6/14/2016 ; Service Code 2K8127 , Lot Number 160880187M , Exp. Date 6/21/2016 ; Service Code 2K8127 , Lot Number 160950226M , Exp. Date 6/28/2016 ; Service Code 2K8127 , Lot Number 160960154M , Exp. Date 6/29/2016 ; Service Code 2K8211 , Lot Number 160530215M , Exp. Date 5/23/2016 ; Service Code 2K8211 , Lot Number 160590067M , Exp. Date 5/29/2016 ; Service Code 2K8211 , Lot Number 160750033M , Exp. Date 6/13/2016 ; Service Code 2K8211 , Lot Number 160880261M , Exp. Date 6/27/2016 ; Service Code 2K8211 , Lot Number 160910039M , Exp. Date 6/29/2016 ;
  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:

4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC 61553-211-08), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Product Codes/Lot Numbers:

Service Code 2H8126 , Lot Number 161080146M , Exp. Date 7/17/2016 ; Service Code 2K8127 , Lot Number 160460115M , Exp. Date 5/10/2016 ; Service Code 2K8127 , Lot Number 160560222M , Exp. Date 5/20/2016 ; Service Code 2K8127 , Lot Number 160610209M , Exp. Date 5/25/2016 ; Service Code 2K8127 , Lot Number 160620148M , Exp. Date 5/26/2016 ; Service Code 2K8127 , Lot Number 160660062M , Exp. Date 5/29/2016 ; Service Code 2K8127 , Lot Number 160680154M , Exp. Date 6/1/2016 ; Service Code 2K8127 , Lot Number 160690126M , Exp. Date 6/2/2016 ; Service Code 2K8127 , Lot Number 160740153M , Exp. Date 6/7/2016 ; Service Code 2K8127 , Lot Number 160800064M , Exp. Date 6/12/2016 ; Service Code 2K8127 , Lot Number 160810161M , Exp. Date 6/14/2016 ; Service Code 2K8127 , Lot Number 160880187M , Exp. Date 6/21/2016 ; Service Code 2K8127 , Lot Number 160950226M , Exp. Date 6/28/2016 ; Service Code 2K8127 , Lot Number 160960154M , Exp. Date 6/29/2016 ; Service Code 2K8211 , Lot Number 160530215M , Exp. Date 5/23/2016 ; Service Code 2K8211 , Lot Number 160590067M , Exp. Date 5/29/2016 ; Service Code 2K8211 , Lot Number 160750033M , Exp. Date 6/13/2016 ; Service Code 2K8211 , Lot Number 160880261M , Exp. Date 6/27/2016 ; Service Code 2K8211 , Lot Number 160910039M , Exp. Date 6/29/2016 ;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1418-2016

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