Piperacillin and Tazobactam Drug Recall [US]

FlagUSUS/Silver Spring: Apotex Corp. recalls some Piperacillin and Tazobactam for Injection Drugs due to precipitation and/or crystallization hazard. FDA: http://ht.ly/kHSlx

Direct link: http://www.fda.gov/Safety/Recalls/ucm349976.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports this recall involves 15 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 to the hospital / healthcare provider / user level.

Hospira, the manufacturer of the recalled drugs, states that administration of precipitated Piperacillin / Tazobactam in an IV bag or IV line may result in local reactions such as phlebitis, renal impairment, end-organ embolism and ischemia, and/or vasculitis (because the precipitate was visible, its particles may be large enough to cause these adverse events). In addition, the precipitation of the drug may not allow delivering a needed therapeutic dose of piperacillin and tazobactam, thus resulting in inadequate treatment of the targeted infection. This could result in adverse health consequences that could range from transient and minor impairment or complaints to permanent impairment of a body function or permanent damage to a body structure.

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

  1. Lot Number: 503B015 – Expiry Date: 04/2013
  2. Lot Number: 503B016 – Expiry Date: 04/2013
  3. Lot Number: 503B019 – Expiry Date: 07/2013
  4. Lot Number: 503B020 – Expiry Date: 07/2013
  5. Lot Number: 503B021 – Expiry Date: 07/2013
  6. Lot Number: 503B022 – Expiry Date: 07/2013
  7. Lot Number: 503B024 – Expiry Date: 08/2013
  8. Lot Number: 503B025 – Expiry Date: 09/2013
  9. Lot Number: 503B026 – Expiry Date: 09/2013
  10. Lot Number: 503B027 – Expiry Date: 09/2013
  11. Lot Number: 503C005 – Expiry Date: 12/2013
  12. Lot Number: 503C006 – Expiry Date: 12/2013
  13. Lot Number: 503C007 – Expiry Date: 01/2014
  14. Lot Number: 503C008 – Expiry Date: 01/2014
  15. Lot Number: 503C018 – Expiry Date: 04/2014

Recalls Direct RIN: 2013-1943
About the RecallsDirect service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.LivingSafely.org
E. & O. E.

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