The Recall Desk
ModerateFDA (Drugs)·D-0430-2022·Announced 2022-02-02

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
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 (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.

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