Drug recall D-0554-2024

Class I Ongoing reported Jun 19, 2024

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

Reason for recall

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

Lots and codes

Lot #: F1030001, Exp. Date 12/31/2024

Recall details

Recalling firm
Sagent Pharmaceuticals, Schaumburg, IL
Quantity
2806 vials
Distribution
Nationwide within the USA.
Type
Voluntary: Firm initiated
Recall initiated
May 28, 2024

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