Recall archive / FDA company announcement
Sagent: Docetaxel Injection, USP — FDA announcement May 29, 2024
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date May 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Docetaxel Injection, USP
- Reason
- Potential presence of particulate matter
- Classification
- Not supplied
- Recalling firm
- Sagent Pharmaceuticals
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- d64143bda7412aec
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | The Docetaxel Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found in the table below. Product was distributed Nationwide from October 11, 2023, to April 11, 2024.; Product | Lot Number | NDC | Expiration Date | Strength; DOCETAXEL INJECTION, USP | F1030001 F1040001 | 25021-254-16 25021-254-08 | 12/2024 12/2024 | 160 mg/16 mL (10 mg/mL) 80 mg/8 mL (10 mg/mL) |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| Product | Lot Number | NDC | Expiration Date | Strength |
|---|---|---|---|---|
| DOCETAXEL INJECTION, USP | F1030001 F1040001 | 25021-254-16 25021-254-08 | 12/2024 12/2024 | 160 mg/16 mL (10 mg/mL) 80 mg/8 mL (10 mg/mL) |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
FOR IMMEDIATE RELEASE - SCHAUMBURG, IL – May 28, 2024 – Sagent Pharmaceuticals today announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The product was distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Docetaxel Injection, USP to the User Level as the result of a customer complaint due to potential presence of particulate matter from the stopper in the drug product. Customers are being notified by a FedEx package that includes arrangements for return of all recalled product. Customers are instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots listed above. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Consumers/distributors/retailers that have product which is being recalled should stop using product and return the recalled product. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Fda listing date
- May 29, 2024
- Company announcement date
- May 28, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.