The Canadian division of Taro Pharmaceuticals (NYSE:TARO) has announced a voluntary Type 1 recall on six lots of Taro-zoledronic Acid Injection.
Type 1 recalls, according to Health Canada, refer to products that could cause serious adverse health consequences or death.
It corresponds to Class 1 recalls from the FDA.
Taro Pharmaceutical‘s consumer-level recall covers 5 mg/100 mL in 100 mL vials.
Zoledronic acid is a bisphosphonate.
The drug is indicated to increase bone mineral density, treat and prevent osteoporosis and for Paget’s disease, a condition associated with bone deformities.
The Brampton, Ontario–based subsidiary is recalling certain lots of the product as it may contain particulate matter higher than requirements allow.
The company has informed Health Canada about the recall.
Taro Pharmaceuticals notes that the particulate matter in the affected lots could lead to adverse events, but it has received no reports of serious adverse effects tied to the product.
The lots in question include JKX1910A, JKX4318A, JKX5541A, HAC2371A, HAC4421A and HAD0156A.
TARO shares have thus far been unaffected by the news, ticking up 0.15% to $34.51.
Taro Pharmaceuticals was founded in 1950 in Haifa, Israel.
Its central markets include Israel, the U.S. and Canada.
The company has had a couple of quality problems in the new millennium. In 2009, FDA sent the company a warning letter to Taro flagging concerns in its manufacturing facility in Brampton, Ontario, Canada. Two years later, FDA agreed the company had resolved the issues.
In 2020, the FDA announced a voluntary recall of lamotrigine tables the company manufactured due to cross-contamination.