Apotex Corp. Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam For Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial Strengths Due to Elevated Levels of Impurities That May Result in Decreased Potency:

Apotex Corp. Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam For Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial Strengths Due to Elevated Levels of Impurities That May Result in Decreased Potency:

For Immediate Release

May 14, 2018

Contact

Consumers

GENCO Pharmaceutical Services
 1- 877-319-8966

Media

Jordan Berman
  jberman@apotex.com
 1 (416) 749-9026 Ext. 7487

Announcement

Apotex Corp. is voluntarily recalling 36 lots of Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial and 4.5 gram/vial strengths, to the consumer/user level. The Piperacillin and Tazobactam for Injection have been found to contain elevated levels of impurities that may result in decreased potency. The affected product is manufactured by Hospira Inc., a Pfizer Company and distributed in the US market by Apotex Corp.

Risk Statement: The decreased potency of Piperacillin and Tazobactam could result in worsening of the infection under treatment and under extreme circumstances lead to serious morbidities depending upon the severity of the illness. Elevated levels of impurities may result in various toxicities, such as liver, renal, and hematological toxicities. There have not been any reports of adverse events related to this recall to date.

Piperacillin and tazobactam for injection is a combination penicillin-class antibacterial and β- lactamase inhibitor, which can be used in adults and children 2 months and older and indicated for treatment of: Intra-abdominal infections, Skin and skin structure infections, Female pelvic infections, Community-acquired pneumonia and Hospital Acquired pneumonia. The Piperacillin and Tazobactam for Injection, USP vials are packaged in a Carton containing 10 single use vials. The affected Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial and 4.5 gram/vial lots include the following and can be identified by NDC numbers stated on the Carton and on the single use vial:

Vial NDC Carton NDC Lot
Number
Expiration
Date
Strength Configuration/Count
60505-0687- 60505-0687-4 501G014 05 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G015 09 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G016 10 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G017 10 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G018 10 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G019 10 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G020 10 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G021 10 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G022 10 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G023 10 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G024 11 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G025 11 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G026 11 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G027 11 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G028 11 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G029 11 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501G030 11 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501H001 12 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501H002 12 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501H003 12 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501H004 12 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501H005 12 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501H006 12 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501H007 12 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501H008 12 2018 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501H009 04 2019 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501H012 06 2019 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501H013 06 2019 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501H018 09 2019 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0687- 60505-0687-4 501H019 09 2019 3.375 gram/vial Carton containing 10 Single Use Vials
60505-0688- 60505-0688-4 502H001 01 2019 4.5 gram/vial Carton containing 10 Single Use Vials
60505-0688- 60505-0688-4 502H003 04 2019 4.5 gram/vial Carton containing 10 Single Use Vials
60505-0688- 60505-0688-4 502H004 04 2019 4.5 gram/vial Carton containing 10 Single Use Vials
60505-0688- 60505-0688-4 502H005 04 2019 4.5 gram/vial Carton containing 10 Single Use Vials
60505-0688- 60505-0688-4 502H009 05 2019 4.5 gram/vial Carton containing 10 Single Use Vials
60505-0688- 60505-0688-4 502H012 05 2019 4.5 gram/vial Carton containing 10 Single Use Vials

The affected Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial and 4.5 gram/vial strengths were distributed Nationwide to wholesalers and one distributor.

Apotex Corp. has notified wholesalers/distributor by recall letter to arrange for return of any recalled product.

Wholesalers/retailers/hospitals/institutions with an existing inventory of the lots subject to this recall should stop use and distribution of the remaining units and quarantine immediately. Healthcare Professionals in your organization should be informed of this recall. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you. For additional assistance, call GENCO Pharmaceutical Services, a subsidiary of FedEx Supply Chain (GENCO) at 1- 877-319-8966 (7:00am – 5:00pm, CST Monday thru Friday), to arrange for their return.

Customers with questions regarding this recall can contact Apotex Corp.  by phone-number 1- 800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday)or email address UScustomerservice@Apotex.com.  Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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

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