Home / Recalls / Edge Pharma, LLC / D-0448-2022

D-0448-2022 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: 6925 syringes

Product Description

Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01

Reason for Recall

CGMP Deviations

Distribution Pattern

nationwide

Code Information

09-2021-10@3 12-09-2021, 09-2021-17@6 12-16-2021, 09-2021-24@8 12-23-2021, 09-2021-30@7 12-29-2021 & 10-2021-13@6 01-11-2022 .

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-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)