Edge Pharma recalls Trypan Blue 0.03% ophthalmic solution due to CGMP deviations. This sterile injection solution for eye use may have manufacturing issues. Consumers should contact the company for details.
CGMP Deviations
Edge Pharma is recalling Trypan Blue 0.03% ophthalmic solution for possible manufacturing issues. This sterile eye injection solution could have quality problems that affect safety.
The product was made under CGMP (Current Good Manufacturing Practice) deviations, which means the manufacturing process may not meet safety standards. This could lead to potential quality issues with the sterile solution.
People who have purchased this ophthalmic solution for eye injections. Those using it for medical procedures are most at risk.
Check for the product name 'Trypan Blue 0.03% 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe' on the label. The NDC code 05446-1348-01 is also associated with this product.
Reach out to Edge Pharma, LLC at 856 Hercules Dr., Colchester, VT 05446 for specific recall information and instructions.
The recall indicates possible manufacturing issues, but the official notice does not specify if the product is safe to use.
The official recall notice does not state a specific action to take for this product.
Look for the product name and NDC code 05446-1348-01 on the label.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0449-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0449-2022 from Edge Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
