10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Number 160460189M , Exp. Date 5/10/2016 ; Lot Number 160480179M , Exp. Date 5/12/2016 ; Lot Number 160520105M , Exp. Date 5/15/2016 ; Lot Number 160530291M , Exp. Date 5/17/2016 ; Lot Number 160540130M , Exp. Date 5/17/2016 ; Lot Number 160550186M , Exp. Date 5/19/2016 ; Lot Number 160560087M , Exp. Date 5/19/2016 ; Lot Number 160590074M , Exp. Date 5/23/2016 ; Lot Number 160620037M , Exp. Date 5/25/2016 ; Lot Number 160630028M , Exp. Date 5/26/2016 ; Lot Number 160660039M , Exp. Date 5/29/2016 ; Lot Number 160730059M , Exp. Date 6/6/2016 ; Lot Number 160740234M , Exp. Date 6/7/2016 ; Lot Number 160800073M , Exp. Date 6/12/2016 ; Lot Number 160820049M , Exp. Date 6/14/2016 ; Lot Number 160890045M , Exp. Date 6/21/2016 ; Lot Number 160970197M , Exp. Date 6/30/2016 ;
  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:

10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02

Product Codes/Lot Numbers:

Lot Number 160460189M , Exp. Date 5/10/2016 ; Lot Number 160480179M , Exp. Date 5/12/2016 ; Lot Number 160520105M , Exp. Date 5/15/2016 ; Lot Number 160530291M , Exp. Date 5/17/2016 ; Lot Number 160540130M , Exp. Date 5/17/2016 ; Lot Number 160550186M , Exp. Date 5/19/2016 ; Lot Number 160560087M , Exp. Date 5/19/2016 ; Lot Number 160590074M , Exp. Date 5/23/2016 ; Lot Number 160620037M , Exp. Date 5/25/2016 ; Lot Number 160630028M , Exp. Date 5/26/2016 ; Lot Number 160660039M , Exp. Date 5/29/2016 ; Lot Number 160730059M , Exp. Date 6/6/2016 ; Lot Number 160740234M , Exp. Date 6/7/2016 ; Lot Number 160800073M , Exp. Date 6/12/2016 ; Lot Number 160820049M , Exp. Date 6/14/2016 ; Lot Number 160890045M , Exp. Date 6/21/2016 ; Lot Number 160970197M , Exp. Date 6/30/2016 ;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1380-2016

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