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Recall Observatory FDA recall evidence

Drug 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

D-0430-2022

December 06, 2021

Class II

Product summary

Firm
Edge Pharma, LLC
Event
Event 89172
Status
Terminated
Classification
Class II
Quantity
2204 vials
Official record key
drug-enforcement:D-0430-2022

Official wording

Reason: CGMP Deviations

Code information: 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, 10-2021-13@7 04-11-2022, 10-2021-20@7 04-18-2022, 10-2021-20@9 04-18-2021 & 10-2021-26@9, 04-24-2022

Distribution pattern: nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations