Edge Pharma recalls 2% Dibutyl Squaric Acid topical solution vials due to CGMP deviations. Affected products were sold between October and December 2021. Consumers should contact the company for details.
CGMP Deviations
Edge Pharma is recalling 2% Dibutyl Squaric Acid topical solution vials that were manufactured with CGMP deviations. This recall affects products sold between October and December 2021. The issue could lead to unsafe drug quality, but the recall does not specify a specific risk of injury.
CGMP deviations refer to failures in the manufacturing process that could result in unsafe drug quality. This means the topical solution might not meet the required safety and purity standards, potentially causing adverse effects if used improperly.
People who purchased or use the recalled Dibutyl Squaric Acid topical solution vials from Edge Pharma between October and December 2021 are affected. Those using the product for medical purposes may be at higher risk due to potential quality issues.
Check for the product name 'Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial' on the label. The recall covers products sold between October and December 2021 with the NDC code 05446-1047-03.
Reach out to Edge Pharma, LLC at 856 Hercules Dr, Colchester VT, 05446 for specific recall details and instructions.
The recall indicates potential CGMP deviations, which could affect product quality, but the official notice does not specify if the product is safe to use.
Contact Edge Pharma, LLC for specific instructions on what to do with the recalled product.
The recall covers products sold between October and December 2021.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0434-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0434-2022 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.
