Home / Recalls / Edge Pharma, LLC / D-0430-2022

D-0430-2022 Class II Terminated

Recalled by Edge Pharma, LLC — Colchester, VT

Recall Details

Product Type
Drugs
Report Date
February 2, 2022
Initiation Date
December 6, 2021
Termination Date
June 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2204 vials

Product Description

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

Reason for Recall

CGMP Deviations

Distribution Pattern

nationwide

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

Other recalls by Edge Pharma, LLC

  • D-0412-2022 Class II — MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.1 (December 6, 2021)
  • D-0403-2022 Class II — Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL (December 6, 2021)
  • D-0448-2022 Class II — Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, (December 6, 2021)
  • D-0419-2022 Class II — Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preserva (December 6, 2021)
  • D-0405-2022 Class II — Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preserva (December 6, 2021)
  • D-0432-2022 Class II — CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortis (December 6, 2021)
  • D-0421-2022 Class II — Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic So (December 6, 2021)
  • D-0429-2022 Class II — Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for (December 6, 2021)
  • D-0442-2022 Class II — Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrin (December 6, 2021)
  • D-0423-2022 Class II — Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0 (December 6, 2021)