Recalls / Class I
Class ID-0553-2024
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, 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
- Brand name
- Docetaxel
- Generic name
- Docetaxel Anhydrous
- Active ingredient
- Docetaxel Anhydrous
- Route
- Intravenous
- NDC
- 25021-254
- FDA application
- ANDA213510
- Affected lot / code info
- Lot #: F1040001, 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
- 762 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-0553-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.