Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot # 02-2020-04@4
Why it was recalled
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Recalling firm
- Firm
- Edge Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 856 Hercules Dr, N/A, Colchester, Vermont 05446-8014
Distribution
- Quantity
- 48 syringes
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-03-19
- FDA classified
- 2021-01-19
- Posted by FDA
- 2021-01-27
- Terminated
- 2023-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0238-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.