Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01
Reported: May 9, 2018 Initiated: April 27, 2018 #D-0804-2018
Product Description
Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01
Reason for Recall
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Details
- Recalling Firm
- Sanofi-Aventis U.S. LLC
- Units Affected
- 19580 vials
- Distribution
- US nationwide
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01. Recalled by Sanofi-Aventis U.S. LLC. Units affected: 19580 vials.
Why was this product recalled? ▼
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 9, 2018. Severity: Moderate. Recall number: D-0804-2018.
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