Hospira, through a distributor (Apotex Corporation), has issued a recall of IV bag-administered antibiotic products, 21 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00. The problem is that these lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams may show precipitation / crystallization in the IV bag or IV line after reconstitution. This crystallization can cause serious personal injury. You can contact our lawyers for a free consultation here.

Hospira has stated that administration of precipitated Piperacillin / Tazobactam in an IV bag or IV line may result in local reactions, including the following:

  • Phlebitis (thrombophlebitis), a condition where blood clots cause swelling in one or more of your veins, typically in the legs;
  • Kidney damage (renal problems);
  • End-organ embolism (blood clot);
  • Ischemia, decrease in blood supply; and/or
  • Vasculitis, inflammation that destroys blood vessels.

In addition, the crystals may prevent the IV bag from delivering the needed therapeutic dose of piperacillin and tazobactam, meaning the antibiotics would not be available to fight the infection they were meant to treat. This could result in a range of health problems, including permanent impairment of a body function or permanent damage to a body structure. Hospira has not received any reports of adverse events related to this recall.

The affected Piperacillin and Tazobactam for Injection, USP 40.5 grams lots include the following Lot Numbers:

  • 503B023 – 08/2013
  • 503B028 – 11/2013
  • 503B029 – 11/2013
  • 503B030 – 11/2013
  • 503B031 – 11/2013
  • 503B032 – 11/2013
  • 503B033 – 11/2013
  • 503C001 -12/2013
  • 503C002 – 12/2013
  • 503C003 – 12/2013
  • 503C004 – 12/2013
  • 503C009 -01/2014
  • 503C010 – 02/2014
  • 503C011 – 02/2014
  • 503C012 – 02/2014
  • 503C014 – 02/2014
  • 503C015 – 04/2014
  • 503C016- 04/2014
  • 503C017- 04/2014
  • 503C019- 04/2014
  • 503C020- 04/2014

The product and all recalled lots are manufactured by Hospira. Apotex is the U.S. distributor of the product and is conducting the recall at the request and on behalf of Hospira.The product can also be identified by NDC number 60505-0773-00 and UPC 360505077304. The product was distributed nationwide in the United States to wholesalers, distributors, HMOs, home infusion and long term care service providers.