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
Reported: June 19, 2024 Initiated: May 28, 2024 #D-0553-2024
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
Reason for Recall
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Details
- Recalling Firm
- Sagent Pharmaceuticals
- Units Affected
- 762 vials
- Distribution
- Nationwide within the USA.
- Location
- Schaumburg, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sagent Pharmaceuticals. Units affected: 762 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 19, 2024. Severity: Critical. Recall number: D-0553-2024.
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