Home / Recalls / Edge Pharma, LLC / D-0429-2022

D-0429-2022 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
1173 vials

Product Description

Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05546 NDC 05446-0572-03

Reason for Recall

CGMP Deviations

Distribution Pattern

nationwide

Code Information

06-2021-11@6 12-08-2021, 07-2021-08@13 01-04-2022, 08-2021-06@6 02-02-2022, 08-2021-20@10 02-16-2022, 08-2021-26@6 02-22-2022, 08-2021-27@7 02-23-2022, 09-2021-02@5 03-01-2022, 09-2021-17@8 03-16-2022 & 09-2021-29@12 03-28-2022

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-0430-2022 Class II — Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per v (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-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)