Recalls / Class I
Class ID-0554-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Docetaxel
- Generic name
- Docetaxel Anhydrous
- Active ingredient
- Docetaxel Anhydrous
- Route
- Intravenous
- NDC
- 25021-254
- FDA application
- ANDA213510
- Affected lot / code info
- Lot #: F1030001, Exp. Date 12/31/2024
Why it was recalled
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Recalling firm
- Firm
- Sagent Pharmaceuticals
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1901 N Roselle Rd Ste 450, N/A, Schaumburg, Illinois 60195
Distribution
- Quantity
- 2806 vials
- Distribution pattern
- Nationwide within the USA.
Timeline
- Recall initiated
- 2024-05-28
- FDA classified
- 2024-06-12
- Posted by FDA
- 2024-06-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0554-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.