FDA recall D-0553-2024

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

Reason for recall

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

Distribution

Nationwide within the USA.

Key facts

Status

Ongoing

Initiation date

2024-05-28

Report date

2024-06-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0553-2024