RecallDepth
Class I Ongoing

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

Company
Sagent Pharmaceuticals
Recall Initiated
May 28, 2024
Posted
June 19, 2024
Recall Number
D-0554-2024
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
2806 vials
Firm Location
Schaumburg, IL, United States

Reason for Recall

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

Distribution

Nationwide within the USA.

Lot / Code Info

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

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