Home / Recalls / Edge Pharma, LLC / D-0407-2022

D-0407-2022 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
860 syringes

Product Description

Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

nationwide

Code Information

08-2021-24@5 12/09/2021, 08-2021-27@2 12/21/2021, 08-2021-31@5 12/14/2021, 09-2021-02@2 12/15/2021, 09-2021-09@2 12/22/2021, 09-2021-15@3 12/29/2021, 09-2021-22@2 01/04/2022 & 10-2021-26@5 02/07/2022

Other recalls by Edge Pharma, LLC

  • D-0434-2022 Class II — Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per v (December 6, 2021)
  • D-0420-2022 Class II — Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per d (December 6, 2021)
  • D-0415-2022 Class II — Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe (December 6, 2021)
  • D-0436-2022 Class II — LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Cont (December 6, 2021)
  • D-0444-2022 Class II — Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multip (December 6, 2021)
  • 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-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-0418-2022 Class II — PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), S (December 6, 2021)