TOPIC: One Lot of IDArubicin Hydrochloride Injection USP, 5 mg/5 mL by Teva: Recall - Due to Presence of Particulate Matter
AUDIENCE: Patient, Health Professional, Pharmacy, Oncology
ISSUE: Teva Pharmaceuticals is recalling one lot, 31329657B, of IDArubicin Hydrochloride Injection USP, 5 mg/5 mL vial. This recall is initiated based on an internal inspection that found particulate matter in one vial of the product identified as silica and iron oxide.
The administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. While the health hazard risk could be severe if particulate matter is infused, Teva’s internal health assessment determined that the likelihood of patient harm is remote or unlikely.
To date, Teva has received no product quality complaints or adverse event reports of this nature for the subject recall lot.
For more information, click on the red "Read Recall" button below.
BACKGROUND: IDArubicin Hydrochloride Injection USP in combination with other approved anti-leukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults.
RECOMMENDATION:
- Any patient who has questions or concerns should first consult with their health care provider.
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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