PlainRecalls
FDA Drug Moderate Class II Terminated

Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01

Reported: February 2, 2022 Initiated: December 6, 2021 #D-0449-2022

Product Description

Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01

Reason for Recall

CGMP Deviations

Details

Recalling Firm
Edge Pharma, LLC
Distribution
nationwide
Location
Colchester, VT

Frequently Asked Questions

What product was recalled?
Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01. Recalled by Edge Pharma, LLC.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on February 2, 2022. Severity: Moderate. Recall number: D-0449-2022.