10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), 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 2T6014 , Lot Number 160390220M , Exp. Date 5/9/2016 ; Service Code 2T6014 , Lot Number 160700029M , Exp. Date 6/8/2016 ; Service Code 2T6636 , Lot Number 160380145M , Exp. Date 5/7/2016 ; Service Code 2T6636 , Lot Number 160390003M , Exp. Date 5/8/2016 ; Service Code 2T6636 , Lot Number 160460177M , Exp. Date 5/15/2016 ; Service Code 2T6636 , Lot Number 160490165M , Exp. Date 5/18/2016 ; Service Code 2T6636 , Lot Number 160550201M , Exp. Date 5/24/2016 ; Service Code 2T6636 , Lot Number 160670237M , Exp. Date 6/6/2016 ; Service Code 2T6636 , Lot Number 160680008M , Exp. Date 6/6/2016 ; Service Code 2T6636 , Lot Number 160700023M , Exp. Date 6/8/2016 ; Service Code 2T6636 , Lot Number 160710003M , Exp. Date 6/9/2016 ; Service Code 2T6636 , Lot Number 160740258M , Exp. Date 6/13/2016 ;
  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 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Product Codes/Lot Numbers:

Service Code 2T6014 , Lot Number 160390220M , Exp. Date 5/9/2016 ; Service Code 2T6014 , Lot Number 160700029M , Exp. Date 6/8/2016 ; Service Code 2T6636 , Lot Number 160380145M , Exp. Date 5/7/2016 ; Service Code 2T6636 , Lot Number 160390003M , Exp. Date 5/8/2016 ; Service Code 2T6636 , Lot Number 160460177M , Exp. Date 5/15/2016 ; Service Code 2T6636 , Lot Number 160490165M , Exp. Date 5/18/2016 ; Service Code 2T6636 , Lot Number 160550201M , Exp. Date 5/24/2016 ; Service Code 2T6636 , Lot Number 160670237M , Exp. Date 6/6/2016 ; Service Code 2T6636 , Lot Number 160680008M , Exp. Date 6/6/2016 ; Service Code 2T6636 , Lot Number 160700023M , Exp. Date 6/8/2016 ; Service Code 2T6636 , Lot Number 160710003M , Exp. Date 6/9/2016 ; Service Code 2T6636 , Lot Number 160740258M , Exp. Date 6/13/2016 ;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1381-2016

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