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Taro Pharmaceuticals announces Type I recall of Taro-zoledronic acid injection

By Brian Buntz | August 11, 2022

Taro PharmaceuticalsThe Canadian division of Taro Pharmaceuticals (NYSE:TARO) has announced a voluntary Type 1 recall of 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.

About The Author

Brian Buntz

The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. Before coming to WTWH, he served as content director focused on connected devices at Informa. In addition, Brian covered the medical device sector for 10 years at UBM. At Qmed, he overhauled the brand’s news coverage and helped to grow the site’s traffic volume dramatically. He had previously held managing editor roles on two of the company’s medical device technology publications. Connect with him on LinkedIn or email at bbuntz@wtwhmedia.com.

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