🔍 RecallPedia

0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250 mL White Smiths Medical Cassette (NDC 615530-933-11) f) 250 mL Yellow Smiths Medical Cassette (NDC 61553-190-50), 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 2H8197 , Lot Number 160730048M , Exp. Date 6/12/2016 ; Service Code 2H8197 , Lot Number 160840111M , Exp. Date 6/22/2016 ; Service Code 2H8197 , Lot Number 160870066M , Exp. Date 6/25/2016 ; Service Code 2H8197 , Lot Number 160880208M , Exp. Date 6/27/2016 ; Service Code 2H8197 , Lot Number 160910038M , Exp. Date 6/29/2016 ; Service Code 2K8189 , Lot Number 160730049M , Exp. Date 6/11/2016 ; Service Code 2K8189 , Lot Number 160810152M , Exp. Date 6/20/2016 ; Service Code 2K8189 , Lot Number 160820330M , Exp. Date 6/21/2016 ; Service Code 2K8189 , Lot Number 160940135M , Exp. Date 7/3/2016 ; Service Code 2K8189 , Lot Number 160960178M , Exp. Date 7/5/2016 ; Service Code 2K8189 , Lot Number 160970201M , Exp. Date 7/6/2016 ; Service Code 2K8197 , Lot Number 160660178M , Exp. Date 6/5/2016 ; Service Code 2K8197 , Lot Number 160670161M , Exp. Date 6/6/2016 ; Service Code 2K8197 , Lot Number 160730253M , Exp. Date 6/12/2016 ; Lot # 160770186M; Exp. 06/16 Lot # 160810189M; Exp. 06/16 Lot # 160840050M; Exp. 06/16 Lot # 160890231M; Exp. 06/16 Lot # 160910228M; Exp. 06/16 Lot # 160560020M; Exp. 05/16 Lot # 160610020C; Exp. 05/16 Lot # 160630014C; Exp. 06/16 Lot # 160660007C; Exp. 06/16 Lot # 160670052C; Exp. 06/16 Lot # 160680067C; Exp. 06/16 Lot # 160740037C; Exp. 06/16 Lot # 160740038C; Exp. 06/16 Lot # 160810067C; Exp. 06/16 Lot # 160840174M; Exp. 06/16 Lot # 160880157M; Exp. 06/16 Lot # 169000103M; Exp. 06/16 Lot # 160600222M; Exp. 05/16 Lot # 160740168M; Exp. 05/16 Lot # 160810051C ;Exp. 05/16 Lot # 160830031C; Exp. 06/16 Lot # 160880019C; Exp. 06/16 Lot # 160880175M; Exp. 06/16 Lot # 160950002C; Exp. 06/16 Lot # 160960172M; Exp. 07/16 Lot # 160950133M; Exp. 07/16
  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:

0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250 mL White Smiths Medical Cassette (NDC 615530-933-11) f) 250 mL Yellow Smiths Medical Cassette (NDC 61553-190-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ;

Product Codes/Lot Numbers:

Service Code 2H8197 , Lot Number 160730048M , Exp. Date 6/12/2016 ; Service Code 2H8197 , Lot Number 160840111M , Exp. Date 6/22/2016 ; Service Code 2H8197 , Lot Number 160870066M , Exp. Date 6/25/2016 ; Service Code 2H8197 , Lot Number 160880208M , Exp. Date 6/27/2016 ; Service Code 2H8197 , Lot Number 160910038M , Exp. Date 6/29/2016 ; Service Code 2K8189 , Lot Number 160730049M , Exp. Date 6/11/2016 ; Service Code 2K8189 , Lot Number 160810152M , Exp. Date 6/20/2016 ; Service Code 2K8189 , Lot Number 160820330M , Exp. Date 6/21/2016 ; Service Code 2K8189 , Lot Number 160940135M , Exp. Date 7/3/2016 ; Service Code 2K8189 , Lot Number 160960178M , Exp. Date 7/5/2016 ; Service Code 2K8189 , Lot Number 160970201M , Exp. Date 7/6/2016 ; Service Code 2K8197 , Lot Number 160660178M , Exp. Date 6/5/2016 ; Service Code 2K8197 , Lot Number 160670161M , Exp. Date 6/6/2016 ; Service Code 2K8197 , Lot Number 160730253M , Exp. Date 6/12/2016 ; Lot # 160770186M; Exp. 06/16 Lot # 160810189M; Exp. 06/16 Lot # 160840050M; Exp. 06/16 Lot # 160890231M; Exp. 06/16 Lot # 160910228M; Exp. 06/16 Lot # 160560020M; Exp. 05/16 Lot # 160610020C; Exp. 05/16 Lot # 160630014C; Exp. 06/16 Lot # 160660007C; Exp. 06/16 Lot # 160670052C; Exp. 06/16 Lot # 160680067C; Exp. 06/16 Lot # 160740037C; Exp. 06/16 Lot # 160740038C; Exp. 06/16 Lot # 160810067C; Exp. 06/16 Lot # 160840174M; Exp. 06/16 Lot # 160880157M; Exp. 06/16 Lot # 169000103M; Exp. 06/16 Lot # 160600222M; Exp. 05/16 Lot # 160740168M; Exp. 05/16 Lot # 160810051C ;Exp. 05/16 Lot # 160830031C; Exp. 06/16 Lot # 160880019C; Exp. 06/16 Lot # 160880175M; Exp. 06/16 Lot # 160950002C; Exp. 06/16 Lot # 160960172M; Exp. 07/16 Lot # 160950133M; Exp. 07/16

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1362-2016

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