AJ-PIP/TAZ (Piperacillin and 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

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals, Hospitals

Identification number:

RA-53912

• Issue
• Who is affected
• Report health or safety concerns

Audience

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.

Key messages

• A recall has been initiated for three (3) lots (lot 7103921, 7103959 and 7103960) of AJ-PIP/TAZ (Piperacillin and Tazobactam) for Injection, 4 g/0.5 g by Jamp Pharma Corporation 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 Jamp on June 23, 2015. Health care professionals are advised to remain vigilant in their follow up with patients who have been administered the impacted lot(s).

             

Issue

Jamp Pharma has initiated a recall due to the potential presence of particulate matter in vials from affected lots of AJ-PIP/TAZ (Piperacillin and 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.

Products affected

The products impacted are:

Product	DIN No.	Lot No.	Distribution Date	Exp. Date
AJ-PIP/TAZ (Piperacillin and Tazobactam for Injection 4 g/ 0.5 g	02391546	7103921 7103959 7103960	AU 26, 2014 NO 11, 2014 SE 24, 2014	NO 15 FE 16 FE 16

Background information

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 three (3) affected lots of AJ-PIP/TAZ (Piperacillin and Tazobactam) 4 g/ 0.5 g for injection are being recalled due to the potential presence of particulate matter.

The root cause of this issue is currently under investigation. 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 Jamp 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 AJ-PIP/TAZ (Piperacillin and Tazobactam) for Injection 4 g/0.5 g, should be reported to Jamp Pharma Corporation or Health Canada.

Jamp Pharma Corporation
1380 – 203, Newton
Boucherville, Qc
J4B 5H2
1-866-399-9091
serviceclient@jamppharma.com

To correct your mailing address or fax number, contact Jamp Pharma Corporation.

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
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-237-9675
Fax: 1-613-946-5636

Original signed by

Stéphane Quirion
Quality Assurance Director
Jamp Pharma Corp.