Edge Pharma, LLC 2022-02-02 Health serious FDA
Health · FDA · Recall #FDA-D-0408-2022
Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8… Recall
Issued February 2, 2022 · Edge Pharma, LLC
In February 2022, Edge Pharma, LLC recalled the Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility
What you should do
- 1 Stop using Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Edge Pharma, LLC 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
- Edge Pharma, LLC
- Category
- Health
- Recall date
- February 2, 2022
- Units affected
- Not reported
- Sold at
- nationwide
- Recall number
- FDA-D-0408-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Edge Pharma, LLC has 30 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.