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

OTTAWA, March 31, 2020 /CNW/ -

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.

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.

Affected products

Company	Product Name/Active Pharmaceutical Ingredient (API)	DIN	Strength	Lot	Expiry
Taro Pharmaceutical Inc.	Taro-Zoledronic acid injection	02415100	5mg/100mL	JKT1520A	April 2020
				JKT1580A	May 2020
				JKT1581A	May 2020
				JKT1642A	May 2020
				JKT1643A	May 2020

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.

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SOURCE Health Canada

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]