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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva IDArubicin Hydrochloride Injection Recalled for Particulate Matter

Agency Publication Date: April 11, 2022
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Summary

Teva Pharmaceuticals USA Inc has recalled 1,565 vials of IDArubicin Hydrochloride Injection USP (5mg/5mL) after finding particulate matter inside the product. Specifically, the injection was found to contain silica and iron oxide, which should not be present in a sterile injectable drug. This recall affects 5mL single-dose vials from lot 31329657B with an expiration date of August 2023. No incidents or injuries have been reported to date.

Risk

Injecting a drug containing silica and iron oxide particles can cause serious health complications, such as inflammation, allergic reactions, or blood vessel blockages that may lead to organ damage. Because this medication is administered intravenously, the presence of foreign particles poses a critical risk to patient safety.

What You Should Do

  1. This recall affects Teva Pharmaceuticals IDArubicin Hydrochloride Injection USP 5mg/5mL (1mg/mL) for intravenous use, packaged in 5mL single-dose vials (NDC 0703-4154-11).
  2. Identify affected units by checking for lot number 31329657B and an expiration date of 08/2023 printed on the vial or carton.
  3. Stop using the recalled product immediately and quarantine any remaining vials from the affected lot to prevent further use.
  4. Contact Teva Pharmaceuticals USA Inc or your distributor to arrange for the return of any unused vials from the recalled lot.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: IDArubicin Hydrochloride Injection USP 5mg/5mL (1mg/mL)by Teva Pharmaceuticals
Variants: 5mL Single Dose Vial, Intravenous use, Rx Only
Lot Numbers:
31329657B (Exp. 08/2023)
NDC:
0703-4154-11

Recall #: D-0765-2022; Quantity: 1565 vials

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89876
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA Inc
Sold By: hospitals; pharmacies; healthcare providers
Manufactured In: United States
Units Affected: 1565 vials
Distributed To: Nationwide
Agency Last Updated: July 7, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.