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

WESTON, FL, April 26, 2013 /CNW/ - 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:

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.

Steve Giuli
Director of Government Affairs and Industry Relations
Apotex Corp.
Direct: 301-654-4964
[email protected]