0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (NDC 61553-463-47), 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8931(NDC 61553-931-02), 400 ml in 500 mL Baxter Intravia Bag, Service Code 2N1119, (NDC 61553-119-84), 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 2K8119 , Lot Number 160480208M , Exp. Date 5/18/2016 ; Service Code 2K8119 , Lot Number 160490134M , Exp. Date 5/19/2016 ; Service Code 2K8119 , Lot Number 160520129M , Exp. Date 5/22/2016 ; Service Code 2K8119 , Lot Number 160530167M , Exp. Date 5/23/2016 ; Service Code 2K8119 , Lot Number 160700126M , Exp. Date 6/8/2016 ; Service Code 2K8119 , Lot Number 160740148M , Exp. Date 6/13/2016 ; Service Code 2K8119 , Lot Number 160750046M , Exp. Date 6/13/2016 ; Service Code 2K8119 , Lot Number 160820124M , Exp. Date 6/21/2016 ; Service Code 2K8171 , Lot Number 160880264M , Exp. Date 6/27/2016 ; Service Code 2K8217 , Lot Number 160380114M , Exp. Date 5/8/2016 ; Service Code 2K8217 , Lot Number 160410116M , Exp. Date 5/11/2016 ; Service Code 2K8217 , Lot Number 160480128M , Exp. Date 5/18/2016 ; Service Code 2K8217 , Lot Number 160540123M , Exp. Date 5/23/2016 ; Service Code 2K8217 , Lot Number 160600196M , Exp. Date 5/30/2016 ; Service Code 2K8217 , Lot Number 160730054M , Exp. Date 6/12/2016 ; Service Code 2K8217 , Lot Number 160740245M , Exp. Date 6/13/2016 ; Service Code 2K8217 , Lot Number 160750048M , Exp. Date 6/13/2016 ; Service Code 2K8217 , Lot Number 160840149M , Exp. Date 6/23/2016 ; Service Code 2K8217 , Lot Number 160900131M , Exp. Date 6/29/2016 ; Service Code 2K8217 , Lot Number 160960139M , Exp. Date 7/5/2016 ; Service Code 2K8463 , Lot Number 160400227M , Exp. Date 5/10/2016 ; Service Code 2K8463 , Lot Number 160630030M , Exp. Date 6/1/2016 ; Service Code 2K8463 , Lot Number 160890243M , Exp. Date 6/28/2016 ; Service Code 2K8463 , Lot Number 160970195M , Exp. Date 7/6/2016 ; Service Code 2K8931 , Lot Number 160970018C , Exp. Date 5/7/2016 ; Service Code 2N1119 , Lot Number 160490041C , Exp. Date 5/19/2016 ;
  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:

0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (NDC 61553-463-47), 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8931(NDC 61553-931-02), 400 ml in 500 mL Baxter Intravia Bag, Service Code 2N1119, (NDC 61553-119-84), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, ;

Product Codes/Lot Numbers:

Service Code 2K8119 , Lot Number 160480208M , Exp. Date 5/18/2016 ; Service Code 2K8119 , Lot Number 160490134M , Exp. Date 5/19/2016 ; Service Code 2K8119 , Lot Number 160520129M , Exp. Date 5/22/2016 ; Service Code 2K8119 , Lot Number 160530167M , Exp. Date 5/23/2016 ; Service Code 2K8119 , Lot Number 160700126M , Exp. Date 6/8/2016 ; Service Code 2K8119 , Lot Number 160740148M , Exp. Date 6/13/2016 ; Service Code 2K8119 , Lot Number 160750046M , Exp. Date 6/13/2016 ; Service Code 2K8119 , Lot Number 160820124M , Exp. Date 6/21/2016 ; Service Code 2K8171 , Lot Number 160880264M , Exp. Date 6/27/2016 ; Service Code 2K8217 , Lot Number 160380114M , Exp. Date 5/8/2016 ; Service Code 2K8217 , Lot Number 160410116M , Exp. Date 5/11/2016 ; Service Code 2K8217 , Lot Number 160480128M , Exp. Date 5/18/2016 ; Service Code 2K8217 , Lot Number 160540123M , Exp. Date 5/23/2016 ; Service Code 2K8217 , Lot Number 160600196M , Exp. Date 5/30/2016 ; Service Code 2K8217 , Lot Number 160730054M , Exp. Date 6/12/2016 ; Service Code 2K8217 , Lot Number 160740245M , Exp. Date 6/13/2016 ; Service Code 2K8217 , Lot Number 160750048M , Exp. Date 6/13/2016 ; Service Code 2K8217 , Lot Number 160840149M , Exp. Date 6/23/2016 ; Service Code 2K8217 , Lot Number 160900131M , Exp. Date 6/29/2016 ; Service Code 2K8217 , Lot Number 160960139M , Exp. Date 7/5/2016 ; Service Code 2K8463 , Lot Number 160400227M , Exp. Date 5/10/2016 ; Service Code 2K8463 , Lot Number 160630030M , Exp. Date 6/1/2016 ; Service Code 2K8463 , Lot Number 160890243M , Exp. Date 6/28/2016 ; Service Code 2K8463 , Lot Number 160970195M , Exp. Date 7/6/2016 ; Service Code 2K8931 , Lot Number 160970018C , Exp. Date 5/7/2016 ; Service Code 2N1119 , Lot Number 160490041C , Exp. Date 5/19/2016 ;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1367-2016

Related Recalls