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FDARecalled Jun 19, 2024 · #D-0554-2024

Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

Hazard

Class I — serious health risk

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Description

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. Classification: Class I Distribution: Nationwide within the USA.

Product details

Product
Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Type
Drugs
Manufacturer
Sagent Pharmaceuticals
Model numbers
F1030001
UPCs