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Additional Lots of Piperacillin and Tazobactam for Injection Recalled

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Apotex Corp. announced in May of 2013 that it is voluntarily recalled 21 additional lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams. The medication shows crystallization, or precipitation, in either the IV bag or IV line after reconstitution. This product was packaged in 300 mL glass vials.

The recalled medications are manufactured by Hospira but distributed by Apotex, who decided to recall the products on behalf of the manufacturer.

Piperacillin and Tazobactam for Injection, USP 40.5 grams is used to treat moderate to severe infections caused by conditions like Appendicitis, skin infections, post-partum endometritis, pelvic inflammatory disease and pneumonia.

Hospira, who is investigating the matter, states that the crystallization in the bag may cause phlebitis, renal impairment, end-organ embolism, ischemia or vasculitis. The affected medication may also block delivery to the patient, resulting in untreated conditions and serious health risks or permanent health damage from persistent infection. Neither Hospira nor Apotex has reported any occurrences of adverse affects related to the recall.

The lots involved in the recall are as follows:

  • 503B023 (Expires 8/2013)
  • 503B028 (Expires 11/2013)
  • 503B029 (Expires 11/2013)
  • 503B030 (Expires 11/2013)
  • 503B031 (Expires 11/2013)
  • 503B032 (Expires 11/2013)
  • 503B033 (Expires 11/2013)
  • 503C001 (Expires 12/2013)
  • 503C002 (Expires 12/2013)
  • 503C003 (Expires 12/2013)
  • 503C004 (Expires 12/2013)
  • 503C009 (Expires 1/2014)
  • 503C010 (Expires 2/2014)
  • 503C011 (Expires 2/2014)
  • 503C012 (Expires 2/2014)
  • 503C014 (Expires 2/2014)
  • 503C015 (Expires 4/2014)
  • 503C016 (Expires 4/2014)
  • 503C017 (Expires 4/2014)
  • 503C019 (Expires 4/2014)
  • 503C020 (Expires 4/2014)

These can also be identified by the NDC number 60505-0773-00 and UPC number 360505077304. These lots were distributed throughout the United States to different types of service providers.

Apotex expects to notify customers through mail and will arrange for a return process for the recalled items. Those with the affected products within their facility should call GENCO (1-877-674-2078). If you or a loved one have been affected by this recall, use the contact form on the right to receive help for any suffering.