Public recall detail

Taro-Zoledronic acid injection drug, used for osteoporosis and Page's disease, recalled because it may contain particulate matter

2022-08-09

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Recall Safety notice
Quick summary

Quick summary: Taro-Zoledronic acid injection drug, used for osteoporosis and Page's disease, recalled because it may contain particulate matter. Date: 2022-08-09.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Taro-Zoledronic acid injection drug, used for osteoporosis and Page's disease, recalled because it may contain particulate matter. Date: 2022-08-09.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

Brand
ProductTaro-Zoledronic acid injection 5mg/100mL (DIN 02415100)
IssueHealth products - Product quality
IdentificationRA-64457

Affected products

ProductTaro Zoledronic acid injection 5mg/100mL
DIN / NPN / authorization02415100
LotJKX1910A JKX4318A JKX5541A HAC2371A HAC4421A HAD0156A
CodesApril-2023 Aug-2023 Nov-2023 Jun-2024 Nov-2024 Jan-2025

Issue

Taro Pharmaceuticals Inc. is recalling all lots of Taro-Zoledronic acid injection 5mg/100mL (DIN 02415100) because they may contain particulate matter. Zoledronic acid is a prescription drug used to treat and prevent osteoporosis and to treat Paget's disease (a condition that disrupts the normal cycle of bone renewal). If particulate matter is injected into a patient, there is potential for injury, such as inflammation or irritation of the veins, infections at the site of injection or in other parts of the body, allergic reactions, and the formation of blood clots that can move to other parts of the body. In the most serious cases, blood clots could move to the lungs and cause lung damage (pulmonary embolism), which can be permanent or fatal. Patients who have been treated with a recalled drug should go to the hospital immediately if they develop difficulty breathing, chest pain or confusion. The Department is monitoring the company's recall and will inform the public if any new health risks are identified.

What you should do

  • Check your product or contact your pharmacist to determine if it is affected. If you have a recalled product, do not use it and return it to your pharmacy for a replacement product and proper disposal.
  • If you have used the recalled product and have health concerns, contact your healthcare provider. Go to the hospital immediately if you develop difficulty breathing, chest pain or confusion.
  • Contact Taro Pharmaceuticals Inc. by calling toll free at 1-800-268-1975 if you have questions about this recall.
  • Report any health product adverse events or complaints to Health Canada.
Additional official information
AudienceGeneral public
CategoryHealth products - Drugs
CompaniesPublished by Health Canada
Published byHealth Canada
Alert / recall typePublic advisory
Identification numberRA-64457
Background{}
CompaniesPublished by Health Canada
AudiencesGeneral public
Source updated2022-08-09

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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