← FDA ENFORCEMENT
D-0553-2024Class I

Sagent Pharmaceuticals

Recalling firm
Sagent Pharmaceuticals
Product type
Drug
Status
Ongoing
Report date
2024-06-19
Distribution
Nationwide within the USA.
Firm state
IL
Product quantity
762 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.