Certain Lots of Taro-Zoledronic acid injection drug, used for osteoporosis and Paget's disease, recalled due to potential presence of particulate matter

Starting date:

March 31, 2020

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product withdrawal

Audience:

General Public

Identification number:

RA-72673

Summary

• Product: Taro-Zoledronic acid injection 5mg/100mL, used for osteoporosis and Paget’s disease
• Issue: Taro Pharmaceuticals Inc. is recalling five lots of Taro-Zoledronic acid injection 5mg/100mL (DIN 02415100), due to the potential presence of particulate matter.
• What to do: Check the lot number on your product or contact your pharmacist to determine whether any of your products are subject to this recall. If you have a recalled product do not take the medication and, contact your healthcare provider to obtain a replacement product. If you have taken a recalled product and have any concerns about your health, contact your healthcare provider.

• Related AWRs
• Media enquiries
• Public enquiries

Issue

Health Canada is advising Canadians that Taro Pharmaceuticals Inc. is recalling five lots of Taro-Zoledronic acid injection 5mg/100mL (DIN 02415100) because of the potential presence of particulate matter in the drug. Zoledronic acid is used to treat and prevent osteoporosis, as well as to treat Paget’s disease (i.e., a condition that causes bone deformities).

If injected, the presence of particles could cause inflammation or irritation of veins that could cause blockage of blood vessels. In the most serious of cases it could cause lung damage, serious allergic reactions or formation of blood clots.

All lots of the drug distributed by Taro Pharmaceuticals Inc. between August 1, 2018, and December 24, 2019, are affected by the recall. Health Canada is monitoring the recall, and should the Department become aware of additional safety information, it will take appropriate action and inform Canadians as necessary.

Who is affected

Patients who are taking, or who have taken, Taro-Zoledronic acid injection 5mg/100mL, or patients who have obtained this product from a pharmacy.

What consumers should do

• Check the lot number on your product or contact your pharmacist to determine whether any of your product is subject to this recall. If you have a recalled product, do not take the medication and contact your healthcare provider to obtain a replacement product. If you become aware of any unusual symptoms or side effects that may be associated with this product, contact your healthcare provider.   
• Contact Taro Pharmaceuticals Inc. toll-free at 1-800-268-1975 for instructions on how to return the recalled product.
• Report any health product-related adverse reactions or complaints to Health Canada.

What Health Canada is doing

Health Canada is monitoring the recall and verifying that the company has effectively addressed the issue. Should additional safety concerns be identified, Health Canada will take appropriate action and inform Canadians as necessary.

Related AWRs

Taro-Zoledronic Acid (2020-03-30)

2020-03-30 | Health products

Recall

Media enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

(613) 957-2991
1-866 225-0709
hcinfo.infosc@canada.ca