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

Source: FDA Drug Recalls
Mon May 14, 2018 6:39PM

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 Î^2- 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 NDCCarton NDCLot
Number
Expiration
Date
StrengthConfiguration/Count
60505-0687-60505-0687-4501G01405 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G01509 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G01610 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G01710 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G01810 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G01910 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G02010 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G02110 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G02210 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G02310 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G02411 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G02511 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G02611 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G02711 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G02811 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G02911 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501G03011 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501b0112 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501b0212 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501b0312 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501b0412 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501b0512 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501b0612 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501b0712 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501b0812 20183.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501b0904 20193.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501b1206 20193.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501b1306 20193.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501b1809 20193.375 gram/vialCarton containing 10 Single Use Vials
60505-0687-60505-0687-4501b1909 20193.375 gram/vialCarton containing 10 Single Use Vials
60505-0688-60505-0688-4502b0101 20194.5 gram/vialCarton containing 10 Single Use Vials
60505-0688-60505-0688-4502b0304 20194.5 gram/vialCarton containing 10 Single Use Vials
60505-0688-60505-0688-4502b0404 20194.5 gram/vialCarton containing 10 Single Use Vials
60505-0688-60505-0688-4502b0504 20194.5 gram/vialCarton containing 10 Single Use Vials
60505-0688-60505-0688-4502b0905 20194.5 gram/vialCarton containing 10 Single Use Vials
60505-0688-60505-0688-4502b1205 20194.5 gram/vialCarton 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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Original Article


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