Docetaxel Injection
FDA Recall NDC 25021-254
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Docetaxel (NDC 25021-254). A significant event, classified as Class I, was initiated on May 28, 2024 by Sagent Pharmaceuticals. The reported reason for this action was: "Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
May 28, 2024
Jun 19, 2024
2806 vials
Recall Profile & Regulatory Data
Event ID
94707
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Sagent Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA.
Product Description
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
Batch or Lot Expiration Information
Lot# : F1030001, Exp. Date 12/31/2024
Affected Packages Involved in this Recall
25021-254-08Product
25021-254-16Product
Class I Ongoing
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
May 28, 2024
Jun 19, 2024
762 vials
Recall Profile & Regulatory Data
Event ID
94707
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Sagent Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA.
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
Batch or Lot Expiration Information
Lot# : F1040001, Exp. Date 12/31/2024
Affected Packages Involved in this Recall
25021-254-08Product
25021-254-16Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
