Taro Pharmaceuticals Inc. Issues Voluntary Type I Recall of Taro-Zoledronic Acid Injection, 5 mg/100 mL, 100 mL Vial Due to Particulate Matter Over Specified Requirements

Rhea-AI Summary

Taro Pharmaceuticals Inc. has initiated a voluntary Type 1 recall of six lots of Taro-Zoledronic Acid Injection, 5 mg/100 mL due to potential contamination with particulate matter. The recall is carried out with Health Canada's awareness, although there have been no reports of serious adverse events linked to these products. Consumers holding affected vials are advised to return them to their pharmacies. The recalled lots include batch numbers JKX1910A, JKX4318A, JKX5541A, HAC2371A, HAC4421A, and HAD0156A, with expiry dates ranging from April 2023 to January 2025.

Positive

• None.

Negative

• Potential contamination could lead to unintended adverse events.
• Recall involves six lots, indicating a significant quality control issue.

BRAMPTON, Ontario--(BUSINESS WIRE)-- Taro Pharmaceuticals Inc. has initiated a voluntary Type 1 recall to the patient level on six (6) lots of Taro-Zoledronic Acid Injection, 5 mg/100 mL in 100 mL vials. The reason for the recall is that product from these lots may contain particulate matter over the specified requirements. This recall is being conducted with the knowledge of Health Canada.

The presence of foreign particulate matter in vials of the affected lots could potentially cause unintended adverse events. Taro has received no reports of serious adverse events associated with this product.

The impacted lots are listed below.

Sr. No	Batch No.	Expiry. Date
1	JKX1910A	April-2023
2	JKX4318A	Aug-2023
3	JKX5541A	Nov-2023
4	HAC2371A	Jun-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 as well as 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) referenced lots listed above and, if so, return the drug to their pharmacy.

To report a suspected adverse event related to Taro-Zoledronic Acid Injection, please contact Taro’s Medication Information line at 1-866-877-5180 or by email at PVCanada@taro.com.

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

• Online at www.healthcanada.gc.ca/medeffect
• Via telephone at 1-866-234-2345
• In writing by completing a Canada Vigilance Reporting Form and
  • Fax at 1-866-678-6789, or
  • Via Mail to: Canada Vigilance Program
    Health Canada, Postal Locator 1908C
    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Forms and the adverse reactions reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220810005801/en/

COMPANY CONTACT

William J. Coote

VP, CFO

(914) 345-9001

William.Coote@taro.com

CONSUMER CONTACT

Taro Pharmaceuticals Inc.

Medical Information

1-866-877-5180

PVCanada@taro.com

Source: Taro Pharmaceuticals Inc.

FAQ

What is the reason for the Taro Pharmaceuticals recall of Taro-Zoledronic Acid Injection?

The recall is due to the discovery of particulate matter in six lots that exceeds specified requirements.

How many lots of Taro-Zoledronic Acid Injection are being recalled?

Six lots of Taro-Zoledronic Acid Injection are being recalled.

Have there been any adverse events reported related to the recalled Taro products?

Taro Pharmaceuticals has received no reports of serious adverse events associated with the recalled products.

What should consumers do if they have the recalled Taro-Zoledronic Acid Injection?

Consumers should check their vials against the listed lot numbers and return the product to their pharmacy if they possess any of the affected lots.

What are the expiry dates of the recalled Taro-Zoledronic Acid Injection lots?

The expiry dates for the recalled lots range from April 2023 to January 2025.