Voluntary Nationwide Recall of 15 Lots of Piperacillin and Tazobactam for Injection, USP 40.5 Grams due to Possibility of

  Voluntary Nationwide Recall of 15 Lots of Piperacillin and Tazobactam for
       Injection, USP 40.5 Grams due to Possibility of Precipitation /
           Crystallization in IV Bag or IV Line Upon Reconstitution

PR Newswire

WESTON, FL, April 26, 2013

WESTON, FL, April 26, 2013 /PRNewswire/ - Apotex Corp. announced today that it
is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary
nationwide recall of 15 lots of Piperacillin and Tazobactam for Injection, USP
40.5 grams, NDC number 60505-0773-00 to the hospital / healthcare provider
/user level. The impacted lots of Piperacillin and Tazobactam for Injection,
USP 40.5 grams may show precipitation / crystallization in IV bag or IV line
after reconstitution.

Hospira  has  stated  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. Hospira has not received any
reports of adverse events related to this recall.

The product is indicated for the treatment of patients with moderate to severe
infections            caused            by             piperacillin-resistant, 
piperacillin/tazobactam-susceptable,  ß-lactamase  producing  strains  of  the 
designated microorganisms in the  specified conditions such as,  Appendicitis, 
Uncomplicated and Complicated skin and skin structures infections,  Postpartum 
Endometritis or Pelvic Inflammatory disease, Community Acquired Pneumonia  and 
Nosocomial Pneumonia. For further details, please refer to the package insert.
The product is packaged in 300 mL glass vials for reconstitution. The affected
Piperacillin and Tazobactam  for Injection,  USP 40.5 grams  lots include  the 
following:

Lot Number Expiry Date
 503B015     04/2013
 503B016     04/2013
 503B019     07/2013
 503B020     07/2013
 503B021     07/2013
 503B022     07/2013
 503B024     08/2013
 503B025     09/2013
 503B026     09/2013
 503B027     09/2013
 503C005     12/2013
 503C006     12/2013
 503C007     01/2014
 503C008     01/2014
 503C018     04/2014

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.

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.  Hospira is  investigating to  determine the  root 
cause.

Apotex will  notify  its  direct  account  customers  by  sending  the  recall 
notification letter by UPS 2^nd day  air service and is arranging for  product 
return of all recalled product.

Anyone with  an  existing  inventory  of  the  product  should  stop  use  and 
distribution, quarantine  the  recalled lots  immediately  and call  GENCO  at 
1-877-674-2078 between  the hours  of 7  a.m. to  5 p.m.  CST, Monday  through 
Friday, to arrange for their return.

For clinical inquiries, please contact Hospira using the information  provided 
below:

Hospira Contact                                                   Areas of
                                Contact Information                Support
Hospira Global                                                 To report
Complaint                                                      adverse events
Management           1-800-441-4100 (8am-5pm CT, M-F)          or product
                     (ProductComplaintsPP@hospira.com)         complaints
Hospira Medical      1-800-615-0187 or medcom@hospira.com
Communications       (Available 24 hours a day/7 days per      Medical
                     week)                                     inquiries

Any adverse reactions or quality problems experienced with the use of this
product may be reported to the U.S. Food and Drug Administration's (FDA)
MedWatch Adverse Events Program either online, by regular mail or by fax.

  *Online: www.fda.gov/medwatch/report.htm

  *Regular mail: use postage-paid, pre-addressed Form FDA3500 available at
    www.fda.gov/MedWatch/getforms.htm

  *Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug
Administration (FDA).

SOURCE Apotex Inc.

Contact:

Steve Giuli
Director of Government Affairs and Industry Relations
Apotex Corp.
Direct: 301-654-4964
sgiuli@apotex.com
 
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