2022-08-11 | NYSE: TARO | Press release

Taro Pharmaceuticals Inc. has initiated a Type 1 voluntary patient recall on six (6) lots of Taro-Zoledronic Acid Injection, 5 mg/100 mL in 100 mL vials. The reason for the recall is that products from these lots may contain particles exceeding specified requirements. This recall is being conducted with the knowledge of Health Canada.

The presence of foreign particles in the vials of the affected lots could potentially cause unforeseen adverse events. Taro received no reportofserious adverse events associated with this product.

The affected batches are listed below.

Sr No

Lot.

Expiry. Date

1

JKX1910A

April-2023

2

JKX4318A

Aug-2023

3

JKX5541A

Nov-2023

4

HAC2371A

June-2024

5

HAC4421A

Nov-2024

6

HAD0156A

Jan-2025

Taro-Zoledronic Acid Injection, 5 mg/100 mL is used to increase bone mineral density, to treat and prevent osteoporosis, and to treat Paget’s disease (a condition that causes bone deformities).

Consumers in possession of Taro-Zoledronic Acid Injection should check to see if the product is one of the six (6) lots referenced above and, if so, return the medication to their pharmacy.

To report a suspected adverse event related to Taro-Zoledronic Acid Injection, please contact Taro’s Drug Information Line at 1-866-877-5180 or by email at [email protected]

Patients can also report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Online at www.healthcanada.gc.ca/medeffect
  • By phone at 1-866-234-2345
  • In writing by completing a Canada Vigilance reporting form and
    • Fax to 1-866-678-6789, or
    • By mail to: Canada Vigilance Program

      Health Canada, Postal Index 1908C

      Ottawa, Ontario K1A 0K9

Postage-paid labels, Canada Vigilance Reporting Forms and Adverse Reaction Reporting Guidelines are available on the MedEffect Canada website at www.healthcanada.gc.ca/medeffect.