Status
Ongoing
Drug Enforcement D-0554-2024
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Classification
Class I
Report Date
June 19, 2024
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 2806 vials
- Reason for recall
- Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide within the USA.
Location & Firm
- Recalling firm
- Sagent Pharmaceuticals
- Address
-
1901 N Roselle Rd Ste 450, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0554-2024
- Event ID
- 94707
- Recall initiation date
- May 28, 2024
- Center classification date
- June 12, 2024
- Code info
- Lot #: F1030001, Exp. Date 12/31/2024
- More code info
- —