🔍 RecallPedia

0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50

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

What Should You Do?

  1. Check if you have this product:
    Lot Number 160380121M , Exp. Date 5/7/2016 ; Lot Number 160420113M , Exp. Date 5/11/2016 ; Lot Number 160450116M , Exp. Date 5/15/2016 ; Lot Number 160470127M , Exp. Date 5/16/2016 ; Lot Number 160480136M , Exp. Date 5/18/2016 ; Lot Number 160490132M , Exp. Date 5/18/2016 ; Lot Number 160520114M , Exp. Date 5/21/2016 ; Lot Number 160530129M , Exp. Date 5/23/2016 ; Lot Number 160590138M , Exp. Date 5/29/2016 ; Lot Number 160600038C , Exp. Date 5/30/2016 ; Lot Number 160620018C , Exp. Date 6/1/2016 ; Lot Number 160700020C , Exp. Date 6/9/2016 ; Lot Number 160740044C , Exp. Date 6/13/2016 ; Lot Number 160750033C , Exp. Date 6/14/2016 ; Lot Number 160760051C , Exp. Date 6/15/2016 ; Lot Number 160770024C , Exp. Date 6/16/2016 ; Lot Number 160810053C , Exp. Date 6/20/2016 ; Lot Number 160820033C , Exp. Date 6/21/2016 ; Lot Number 160880014C , Exp. Date 6/27/2016 ; Lot Number 160940015C , Exp. Date 7/2/2016 ; Lot Number 160950034C , Exp. Date 7/4/2016 ; Lot Number 160960019C , Exp. Date 7/5/2016 ;
  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:

0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50

Product Codes/Lot Numbers:

Lot Number 160380121M , Exp. Date 5/7/2016 ; Lot Number 160420113M , Exp. Date 5/11/2016 ; Lot Number 160450116M , Exp. Date 5/15/2016 ; Lot Number 160470127M , Exp. Date 5/16/2016 ; Lot Number 160480136M , Exp. Date 5/18/2016 ; Lot Number 160490132M , Exp. Date 5/18/2016 ; Lot Number 160520114M , Exp. Date 5/21/2016 ; Lot Number 160530129M , Exp. Date 5/23/2016 ; Lot Number 160590138M , Exp. Date 5/29/2016 ; Lot Number 160600038C , Exp. Date 5/30/2016 ; Lot Number 160620018C , Exp. Date 6/1/2016 ; Lot Number 160700020C , Exp. Date 6/9/2016 ; Lot Number 160740044C , Exp. Date 6/13/2016 ; Lot Number 160750033C , Exp. Date 6/14/2016 ; Lot Number 160760051C , Exp. Date 6/15/2016 ; Lot Number 160770024C , Exp. Date 6/16/2016 ; Lot Number 160810053C , Exp. Date 6/20/2016 ; Lot Number 160820033C , Exp. Date 6/21/2016 ; Lot Number 160880014C , Exp. Date 6/27/2016 ; Lot Number 160940015C , Exp. Date 7/2/2016 ; Lot Number 160950034C , Exp. Date 7/4/2016 ; Lot Number 160960019C , Exp. Date 7/5/2016 ;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1366-2016

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