Why it was recalled
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: F1040001, Exp. Date 12/31/2024
Where it was sold
Nationwide within the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0553-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- May 28, 2024
- FDA report date
- Jun 19, 2024
- Quantity
- 762 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0553-2024, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 94707
- Address
- 1901 N Roselle Rd Ste 450
- Code information
- Lot #: F1040001, Exp. Date 12/31/2024
- Postal code
- 60195
- Report date
- Jun 19, 2024
- Product type
- Drugs
- Recall number
- D-0553-2024
- Classification
- Class I
- Recalling firm
- Sagent Pharmaceuticals
- Product quantity
- 762 vials
- Reason for recall
- Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the USA.
- Recall initiation date
- May 28, 2024
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 12, 2024