Dibutyl Squaric Acid Topical Solution Recalled Due to Manufacturing Deviations
Edge Pharma, LLC is recalling 63 vials of Dibutyl Squaric Acid Topical Solution (2%, 10 mL per vial) nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall with no reported illnesses or injuries. The hazard is related to manufacturing deviations rather than a direct contamination or safety threat with documented harm, placing it in the Moderate category per the rubric.
Plain-English summary
Edge Pharma, LLC is recalling Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, distributed nationwide. The product is manufactured by Edge Pharma, LLC, located at 856 Hercules Drive, Colchester, Vermont 05446, with NDC 05446-1047-03.
The recall was initiated on December 6, 2021, due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. This is a voluntary recall initiated by the firm. A total of 63 vials are affected, with lot codes 09-2021-15@5 (dated December 14, 2021) and 10-2021-01@4 (dated December 30, 2021).
The FDA classified this as a Class II recall on January 24, 2022, and the recall was terminated on June 7, 2023. Consumers or healthcare providers who have this product should discontinue use and contact Edge Pharma, LLC or consult their healthcare provider for guidance.
The recalled product
- Product
- Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Topical Solution
- Hazard
- cgmp-deviation
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 09-2021-15@5 12-14-2021 & 10-2021-01@4 12-30-2021
Distribution
Distributed nationwide across the United States.
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