FDA-Drug2024-06-19Class I

Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

Sagent Pharmaceuticals
Hazard

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

Sold states
Nationwide within the USA.
Affected count
762 vials
Manufactured in
1901 N Roselle Rd Ste 450, N/A, Schaumburg, IL, United States
Products
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0553-2024

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