FDA Recall D-0553-2024

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, 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

Lot / code: Lot #: F1040001, Exp. Date 12/31/2024

Quantity: 762 vials

Reason for recall

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

Recall record

Recall number: D-0553-2024
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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