FDA Recall D-0554-2024

Sagent Pharmaceuticals · Schaumburg, IL

Class I — life-threatening Ongoing 716 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

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

Quantity: 2806 vials

Reason for recall

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

Recall record

Recall number: D-0554-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide within the USA.
Recall initiated: 2024-05-28
Classified by FDA Center: 2024-06-12
FDA published: 2024-06-19
Recalling firm: Sagent Pharmaceuticals
Firm location: Schaumburg, IL

Drug identification

Brand name(s): DOCETAXEL
Generic name(s): DOCETAXEL ANHYDROUS
Manufacturer(s): Sagent Pharmaceuticals
NDC(s): 25021-254
Route(s): INTRAVENOUS

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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