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Mylan Piperacillin-Tazobactam for Injection - Recall Due to the Potential Presence of Particulate Matter
- Starting date:
- June 24, 2015
- Posting date:
- June 24, 2015
- Type of communication:
- Dear Healthcare Professional Letter
- Source of recall:
- Health Canada
- Important Safety Information
- Healthcare Professionals
- Identification number:
Health care professionals working in hospitals and clinics.
Please distribute to relevant Departments: Pharmacy, Paediatrics, Geriatrics, Internal Medicine, Nursing, Intensive Care and/or other Departments as required, affiliated clinics and other involved professional staff and post this notice in your institution.
- A recall has been initiated for one (1) lot (lot 7103985) of Piperacillin-Tazobactam for Injection, 3 g/0.375 g and one (1) lot (lot 7103921) of Piperacillin-Tazobactam for Injection, 4 g/0.5 g by Mylan Pharmaceuticals ULC, due to the potential presence of particulate matter.
- If infused, particulate matter could potentially lead to patient harm including phlebitis and thrombo-embolism, which could result in death.
- Vials of the affected lot should not be used and should be returned as outlined in the Recall Notice issued by Mylan on June 23, 2015. Health care professionals are advised to remain vigilant in their follow up with patients who have been administered the impacted lots.
Mylan Pharmaceuticals ULC has initiated a recall due to the potential presence of particulate matter in vials from affected lots of Piperacillin-Tazobactam for Injection (see table below).
The presence of particulate matter could pose the following risks, if injected: local inflammation, phlebitis, allergic response and/or embolization in the body and infection.
|Product||DIN No.||Lot No.||Distribution Date||Exp. Date|
|Mylan-Piperacillin and Tazobactam for Injection 3 g/ 0.375 g||02391538||7103985||Aug.27, 2014||Feb. 2016|
|AJ-Pip/Taz (Piperacillin and Tazobactam for Injection) 4 g/ 0.5 g||02391546||7103921||Dec. 1, 2014||Nov. 2015|
Piperacillin-Tazobactam for Injection is indicated for the treatment of systemic and/or local bacterial infections caused by piperacillin-resistant, piperacillin/tazobactam susceptible, β-lactamase-producing strains.
The recent inspection of retention samples of two lots (lots 7103985 and 7103921) of Piperacillin-Tazobactam (3 g/ 0.375 g, and 4 g/ 0.5 g, respectively) revealed the presence of particulate matter in some of the vials inspected. These are the only lots within expiry distributed by Mylan Pharmaceuticals ULC to the Canadian market to date.
The two (2) affected lots of Piperacillin-Tazobactam (3 g/ 0.375 g and 4 g/ 0.5 g) for injection are being recalled.
The root cause of this issue is currently under investigation by Mylan Pharmaceuticals. No complaints or adverse event reports have been received in relation to this product from these lots.
Who is affected
Information for consumers
Consumers should contact their health care professional for more information.
Information for health care professionals
Vials of the affected lots of Piperacillin-Tazobactam should not be used and should be returned as outlined in the Recall Notice issued by Mylan on June 23, 2015.
Please inform other health care professionals in your organization of this recall notification. Health care professionals should also notify affiliated staff administering this product in a clinic setting.
If your institution or pharmacy has distributed the affected product lots further, notify recipients that they may have received the product lots identified above and ask them to return the affected product as indicated in the Recall Notice.
Action taken by Health Canada
Health Canada is communicating this important safety information to health care professionals and to the public through its MedEffect Canada website. Health Canada is also monitoring the recalls and the implementation of necessary corrective and preventive actions.
Report health or safety concerns
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious local inflammation, phlebitis, allergic response and/or embolization in the body or other serious or unexpected infection or unexpected side effects in patients receiving Piperacillin-Tazobactam for Injection 3 g/0.375 g, and 4 g/0.5 g, respectively, should be reported to Mylan Pharmaceuticals ULC or Health Canada.
Mylan Pharmaceuticals ULC
85 advance Road
Etobicoke, ON M8Z 2S6
To correct your mailing address or fax number, contact Mylan Pharmaceuticals ULC.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Calling toll-free at 1-866-234-2345; or
- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax
For other health product inquiries related to this communication, contact Health Canada at:
Health Products and Food Branch Inspectorate
Original signed by
Senior Director, Quality
Mylan Pharmaceuticals ULC
For more informationThe manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.
- Date modified: