Drug 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
D-0554-2024
Product summary
- Event
- Event 94707
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 2806 vials
- Official record key
drug-enforcement:D-0554-2024
Official wording
Reason: Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Code information: Lot #: F1030001, Exp. Date 12/31/2024
Distribution pattern: Nationwide within the USA.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter