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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

Sagent Pharmaceuticals 2024-06-19 Health critical FDA
Health · FDA · Recall #FDA-D-0554-2024

Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx… Recall

Issued June 19, 2024 · Sagent Pharmaceuticals

In June 2024, Sagent Pharmaceuticals recalled the Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

What you should do

  1. 1 Stop using Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Sagent Pharmaceuticals to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Sagent Pharmaceuticals
Category
Health
Recall date
June 19, 2024
Units affected
Not reported
Sold at
Nationwide within the USA.
Recall number
FDA-D-0554-2024
Made in
United States
Issuing agency
FDA

In context

  • Sagent Pharmaceuticals has 2 recalls in our database, including 1 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 737th Health recall we've logged in 2024.
Read the official FDA notice

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