Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.
Reported: April 10, 2024 Initiated: April 2, 2024 #D-0433-2024
Product Description
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.
Reason for Recall
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Details
- Recalling Firm
- X-Gen Pharmaceuticals Inc.
- Units Affected
- 1283 vials
- Distribution
- Nationwide in the US
- Location
- Horseheads, NY
Frequently Asked Questions
What product was recalled? ▼
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.. Recalled by X-Gen Pharmaceuticals Inc.. Units affected: 1283 vials.
Why was this product recalled? ▼
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 10, 2024. Severity: Low. Recall number: D-0433-2024.
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