Docetaxel Injection, Solution, Concentrate
FDA Recall NDC 0955-1021
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Docetaxel (NDC 0955-1021). A significant event, classified as Class II, was initiated on Apr 27, 2018 by Sanofi-aventis U.s. Llc. The reported reason for this action was: "Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Apr 27, 2018
May 09, 2018
19580 vials
Recall Profile & Regulatory Data
Event ID
79964
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sanofi-Aventis U.S. LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US nationwide
Termination Date
Jan 20, 2021
Product Description
Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01
Batch or Lot Expiration Information
Lot# : 7F307A, 7F307C, Exp 01/2019
Affected Packages Involved in this Recall
0955-1021-04Product
0955-1020-01Product
0955-1022-08Product
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.
