Edge Pharma, LLC: Drug Recall

Recall #D-0421-2022 · 12/06/2021

Class II: Risk

Recall Details

Recall Number: D-0421-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Edge Pharma, LLC
Status: Terminated
Date Initiated: 12/06/2021
Location: Colchester, VT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2562 syringes

Reason for Recall

Lack of Assurance of Sterility

Product Description

Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01

Distribution Pattern

nationwide

Other Recalls by Edge Pharma, LLC

Class II: Risk 12/06/2021

Lack of Assurance of Sterility.
Class II: Risk 12/06/2021

Lack of Assurance of Sterility
Class II: Risk 12/06/2021

Lack of Assurance of Sterility
Class II: Risk 12/06/2021

CGMP Deviations
Class II: Risk 12/06/2021

CGMP Deviations

View all recalls by Edge Pharma, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.