10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-203-27

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Number 160380150M , Exp. Date 5/7/2016 ; Lot Number 160420180M , Exp. Date 5/11/2016 ; Lot Number 160450106M , Exp. Date 5/14/2016 ; Lot Number 160480109M , Exp. Date 5/17/2016 ; Lot Number 160660210M , Exp. Date 6/5/2016 ; Lot Number 160700121M , Exp. Date 6/8/2016 ; Lot Number 160770215M , Exp. Date 6/16/2016 ; Lot Number 160820099M , Exp. Date 6/20/2016 ; Lot Number 160880167M , Exp. Date 6/26/2016 ; Lot Number 161080045M , Exp. Date 7/16/2016 ;
  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 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-203-27

Product Codes/Lot Numbers:

Lot Number 160380150M , Exp. Date 5/7/2016 ; Lot Number 160420180M , Exp. Date 5/11/2016 ; Lot Number 160450106M , Exp. Date 5/14/2016 ; Lot Number 160480109M , Exp. Date 5/17/2016 ; Lot Number 160660210M , Exp. Date 6/5/2016 ; Lot Number 160700121M , Exp. Date 6/8/2016 ; Lot Number 160770215M , Exp. Date 6/16/2016 ; Lot Number 160820099M , Exp. Date 6/20/2016 ; Lot Number 160880167M , Exp. Date 6/26/2016 ; Lot Number 161080045M , Exp. Date 7/16/2016 ;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1382-2016

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