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FDA Alerts

  • Hospira Announces Voluntary Nationwide Recall of One Lot of 0.5% Marcaine™ (Bupivacaine HCI Injection, USP), 30 ML, Single-Dose, Preservative-Free Vial Due to Visible Particulates

  • June 17, 2014 - Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine™ (Bupivacaine HCl Injection, USP), 30 mL, Single-dose Vial – Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. The recall is due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira has attributed the embedded particulate to a supplier’s glass defect. Hospira is working with its supplier on implementing corrective and preventive actions. 

     http://www.fda.gov/Safety/Recalls/ucm401592.htm