Taro-Zoledronic Acid: The affected lots may contain particulate matter
Summary
Check your product or contact your pharmacist to determine if it is recalled. If you have a recalled product, do not use it and return it to your pharmacy for a replacement product and proper disposal. If you have used the recalled product and have health concerns, contact your healthcare provider. Go to the hospital immediately if you develop difficulty breathing, chest pain or confusion.
Affected products
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot |
|---|---|---|---|---|---|
Taro-Zoledronic Acid |
Taro-Zoledronic Acid |
DIN 02415100 |
Solution |
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5 MG / 100 ML |
JKX1910A, JKX4318A, JKX5541A, HAC2371A, HAC4421A, HAD0156A |
Issue
Taro Pharmaceuticals Inc. is recalling all lots of Taro-Zoledronic acid injection 5mg/100mL (DIN 02415100) because they may contain particulate matter.
Zoledronic acid is a prescription drug used to treat and prevent osteoporosis and to treat Paget's disease (a condition that disrupts the normal cycle of bone renewal).
If particulate matter is injected into a patient, there is potential for injury, such as inflammation or irritation of the veins, infections at the site of injection or in other parts of the body, allergic reactions, and the formation of blood clots that can move to other parts of the body. In the most serious cases, blood clots could move to the lungs and cause lung damage (pulmonary embolism), which can be permanent or fatal. Patients who have been treated with a recalled drug should go to the hospital immediately if they develop difficulty breathing, chest pain or confusion.
The Department is monitoring the company's recall and will inform the public if any new health risks are identified.
What you should do
- Check your product or contact your pharmacist to determine if it is affected. If you have a recalled product, do not use it and return it to your pharmacy for a replacement product and proper disposal.
- If you have used the recalled product and have health concerns, contact your healthcare provider. Go to the hospital immediately if you develop difficulty breathing, chest pain or confusion.
- Contact Taro Pharmaceuticals Inc. by calling toll free at 1-800-268-1975 if you have questions about this recall.
- Report any health product adverse events or complaints to Health Canada.
Additional information
Previous recalls or alerts
Background
Depth of recall: End Users
Details
TARO PHARMACEUTICALS INC.
130 East Drive, Brampton
Ontario L6T 1C1