Cantharidin PLUS topical suspension recalled for manufacturing deviations
Edge Pharma, LLC is recalling 2,204 vials of Cantharidin PLUS, a topical gel-forming suspension used to treat skin conditions. The recall is due to manufacturing quality control deviations discovered during production.
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: This is an FDA Class II recall with no reported injuries or illnesses. The hazard is manufacturing quality control deviations rather than a known contaminant or safety threat, making this a moderate-level precautionary recall.
Plain-English summary
Edge Pharma, LLC is voluntarily recalling 2,204 vials of Cantharidin PLUS (Cantharidin/Salicylic Acid Gel-Forming Suspension), a topical medication supplied in 10 mL multiple-dose vials for professional use. The product was distributed nationwide.
The FDA classified this as a Class II recall due to current good manufacturing practice (CGMP) deviations identified by the manufacturer. The specific manufacturing defects are cited as the reason for the recall.
Patients and healthcare providers who have received or dispensed Cantharidin PLUS should contact Edge Pharma or the FDA if they have questions about whether their medication is affected. The recall was initiated on December 6, 2021, and the FDA center classified it on January 24, 2022.
The recalled product
- Product
- Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose Vials for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0970-03
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Topical / Dermatological
- Affected units
- 2,204
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 (20)
- 06-2021-09@9 12-06-2021
- 06-2021-16@11 12-13-2021
- 06-2021-23@7 12-20-2021
- 06-2021-30@11 12-27-2021
- 07-2021-07@9 01-03-2022
- 07-2021-13@6 01-09-2021
- 07-2021-14@5 01-10-2022
- 07-2021-21@8 01-17-2022
- 07-2021-26@10 01-22-2022
- 08-2021-04@5 01-31-2022
- 08-2021-09@11 02-05-2022
- 08-2021-10@6 02-06-2022
- 08-2021-17@5 02-13-2022
- 08-2021-25@4 02-21-2022
- 09-2021-01@8 02-28-2022
- 09-2021-08@8 03-07-2022
- 09-2021-15@6 03-14-2022
- 09-2021-21@8 03-20-2022
- 09-2021-27@10 03-26-2022
- 10-2021-06@8 04-04-2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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