Print | Need Larger Text? | Share

Recall of Lot 7101490 of PPC Piperacillin/Tazobactam for Injection, 4.5g/vial - For Health Professionals

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

(PDF Version - 1045 K)

Contact: Health Products and Food Branch Inspectorate

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Pharmaceutical Partners of Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information Piperacillin/Tazobactam for Injection from Pharmaceutical Partners of Canada Inc.

December 23, 2008

Subject: Recall of Lot 7101490 of PPC Piperacillin/Tazobactam for Injection, 4.5g/vial

Dear Health Care Professional,

PPC (Pharmaceutical Partners of Canada Inc.), in consultation with Health Canada is recalling Lot 7101490 of Piperacillin/Tazobactam for Injection, 4.5 g/vial (DIN 02305615) due to the finding of the presence of foreign particulate matter in some vials from this lot.

Piperacillin/Tazobactam for Injection is indicated for the treatment of patients with systemic and/or local bacterial infections, caused by piperacillin-resistant piperacillin/tazobactam-susceptible, ß-lactamase-producing strains of the designated microorganisms in the specified conditions: intra-abdominal infections, skin and skin structure infections, gynaecological infections, community-acquired lower respiratory tract infections, nosocomial pneumonia. It may be used in hospitals, institutional or long term care facilities or in home care settings.

The vials from this lot could lead to the administration of foreign, particulate matter into the blood stream that may lead to potential adverse events such as phlebitis or thrombosis. The physiological effect of the foreign particulate matter will depend on the size of the particle, particle composition, number of particles, the rate at which the particles are introduced, and the state of the patient receiving the product. Patients who have had previous trauma, undergone major surgery, or suffer from other conditions that adversely affect the microvascular blood supply of tissues and vital organs may be at greater risk.

Please examine your stock immediately to determine if you have any of the recalled product lot number on hand. If yes, discontinue use immediately and return the recalled product back to the original point of purchase. PPC Inc. will work with the pharmacy/hospital at the original point of purchase to have the recalled product shipped back to PPC Inc.

Patients should be advised to consult their health care professional if they have used this product and are concerned about their health.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them.  Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.  Any case of serious or other serious or unexpected adverse reactions in patients receiving Piperacillin/Tazobactam for Injection should be reported to Pharmaceutical Partners of Canada Inc. or Health Canada at the following addresses:

Sincerely,

original signed by

Philip Hoy
Director, QA/QC