Docetaxel Injection recall
FDA recall D-0554-2024 · initiated May 28, 2024
Sagent Pharmaceuticals recalled Docetaxel Injection in May 2024 — an FDA Class I recall (D-0554-2024) because Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2806 vials
Details
- Product
- 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
- Recalling company
- Sagent
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the USA.
- Initiated
- May 28, 2024
- FDA report date
- Jun 19, 2024
Frequently asked
- Was Docetaxel Injection recalled?
- Sagent Pharmaceuticals recalled Docetaxel Injection in May 2024 — an FDA Class I recall (D-0554-2024) because Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Docetaxel Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0554-2024 was: Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
- Is a recalled Docetaxel Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Docetaxel Injection are affected?
- Distributed: Nationwide within the USA.. The recall covers these lots — Lot #: F1030001, Exp. Date 12/31/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0554-2024.