🔍 RecallPedia

0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Class I - Dangerous
💊 Drugs Recalled: May 5, 2016 Pharmedium Services Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Service Code 2N1488 , Lot Number 160520176M , Exp. Date 5/22/2016 ; Service Code 2N1488 , Lot Number 160600059M , Exp. Date 5/30/2016 ; Service Code 2N1488 , Lot Number 160970115M , Exp. Date 7/5/2016 ; Service Code 2N1489 , Lot Number 160490027C , Exp. Date 5/19/2016 ; Service Code 2N1489 , Lot Number 160560032C , Exp. Date 5/26/2016 ; Service Code 2N1489 , Lot Number 160620024C , Exp. Date 6/1/2016 ; Service Code 2N1489 , Lot Number 160630029C , Exp. Date 6/2/2016 ; Service Code 2N1489 , Lot Number 160670059C , Exp. Date 6/6/2016 ; Service Code 2N1489 , Lot Number 160700047C , Exp. Date 6/9/2016 ; Service Code 2N1489 , Lot Number 160730025C , Exp. Date 6/12/2016 ; Service Code 2N1489 , Lot Number 160810057C , Exp. Date 6/20/2016 ; Service Code 2R3332-5 , Lot Number 160420156M , Exp. Date 5/11/2016 ; Service Code 2R3332-5 , Lot Number 160470152M , Exp. Date 5/16/2016 ; Service Code 2R3332-5 , Lot Number 160620035M , Exp. Date 5/31/2016 ; Service Code 2R3332-5 , Lot Number 160770159M , Exp. Date 6/16/2016 ; Service Code 2R3332-5 , Lot Number 160830044M , Exp. Date 6/21/2016 ; Service Code 2R3332-5 , Lot Number 160970032M , Exp. Date 7/5/2016 ; Service Code 3332NO , Lot Number 160380115M , Exp. Date 5/7/2016 ; Service Code 3332NO , Lot Number 160420112M , Exp. Date 5/11/2016 ; Service Code 3332NO , Lot Number 160540138M , Exp. Date 5/24/2016 ; Service Code 3332NO , Lot Number 160660215M , Exp. Date 6/5/2016 ; Service Code 3332NO , Lot Number 160690125M , Exp. Date 6/7/2016 ; Service Code 3332NO , Lot Number 160750228M , Exp. Date 6/14/2016 ; Service Code 3332NO , Lot Number 160900145M , Exp. Date 6/28/2016 ; Service Code 3332NO , Lot Number 160950153M , Exp. Date 7/4/2016 ;
  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:

0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Product Codes/Lot Numbers:

Service Code 2N1488 , Lot Number 160520176M , Exp. Date 5/22/2016 ; Service Code 2N1488 , Lot Number 160600059M , Exp. Date 5/30/2016 ; Service Code 2N1488 , Lot Number 160970115M , Exp. Date 7/5/2016 ; Service Code 2N1489 , Lot Number 160490027C , Exp. Date 5/19/2016 ; Service Code 2N1489 , Lot Number 160560032C , Exp. Date 5/26/2016 ; Service Code 2N1489 , Lot Number 160620024C , Exp. Date 6/1/2016 ; Service Code 2N1489 , Lot Number 160630029C , Exp. Date 6/2/2016 ; Service Code 2N1489 , Lot Number 160670059C , Exp. Date 6/6/2016 ; Service Code 2N1489 , Lot Number 160700047C , Exp. Date 6/9/2016 ; Service Code 2N1489 , Lot Number 160730025C , Exp. Date 6/12/2016 ; Service Code 2N1489 , Lot Number 160810057C , Exp. Date 6/20/2016 ; Service Code 2R3332-5 , Lot Number 160420156M , Exp. Date 5/11/2016 ; Service Code 2R3332-5 , Lot Number 160470152M , Exp. Date 5/16/2016 ; Service Code 2R3332-5 , Lot Number 160620035M , Exp. Date 5/31/2016 ; Service Code 2R3332-5 , Lot Number 160770159M , Exp. Date 6/16/2016 ; Service Code 2R3332-5 , Lot Number 160830044M , Exp. Date 6/21/2016 ; Service Code 2R3332-5 , Lot Number 160970032M , Exp. Date 7/5/2016 ; Service Code 3332NO , Lot Number 160380115M , Exp. Date 5/7/2016 ; Service Code 3332NO , Lot Number 160420112M , Exp. Date 5/11/2016 ; Service Code 3332NO , Lot Number 160540138M , Exp. Date 5/24/2016 ; Service Code 3332NO , Lot Number 160660215M , Exp. Date 6/5/2016 ; Service Code 3332NO , Lot Number 160690125M , Exp. Date 6/7/2016 ; Service Code 3332NO , Lot Number 160750228M , Exp. Date 6/14/2016 ; Service Code 3332NO , Lot Number 160900145M , Exp. Date 6/28/2016 ; Service Code 3332NO , Lot Number 160950153M , Exp. Date 7/4/2016 ;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1372-2016

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