Taro Pharmaceuticals ( NYSE: TARO ) said it began a voluntary type 1 recall of six lots of bone disorder drug Taro-Zoledronic Acid injection as they may contain particulate matter over the specified requirements.
The Israeli company said the recall was being conducted with the knowledge of Health Canada.
Type 1 recall is the most serious of all recalls according to Health Canada. The regulator notes that this recall is assigned to a situation in which there is a reasonable probability that the use of (or exposure to) a recalled product will cause serious adverse health consequences or death.
Taro said the presence of foreign particulate matter in the affected lots — of Zoledronic Acid Injection, 5 mg/100 mL in 100 mL vials — could potentially cause unintended adverse events. However, the company has received no reports of serious adverse events associated with the product.
The medicine is used to increase bone mineral density, to treat and prevent osteoporosis, and to treat Paget's disease (a condition that causes bone deformities), the company noted in its Aug. 11 press release.
Taro added that if consumers have any product from the six referenced lots they should return the drug to their pharmacy.
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Taro recalls certain lots of bone disorder drug in Canada on particulate matter concerns