FDA recall D-0238-2021

Product

Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This is a compounded (re-packaged) drug. Not for Resale, Hospital/Office use only. Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178

Reason for recall

Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-03-19

Report date

2021-01-27

Termination date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Colchester, VT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0238-2021