X-Gen Pharmaceuticals Inc. 2024-04-10 Health moderate FDA
Health · FDA · Recall #FDA-D-0434-2024
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard… Recall
Issued April 10, 2024 · X-Gen Pharmaceuticals Inc.
In April 2024, X-Gen Pharmaceuticals Inc. recalled the Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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'.
What you should do
- 1 Stop using Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact X-Gen Pharmaceuticals Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- X-Gen Pharmaceuticals Inc.
- Category
- Health
- Recall date
- April 10, 2024
- Units affected
- Not reported
- Sold at
- Nationwide in the US
- Recall number
- FDA-D-0434-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- X-Gen Pharmaceuticals Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.