D-0238-2021 Class II Terminated
FDA drug recall D-0238-2021 was initiated by Edge Pharma, LLC on March 19, 2020 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired. The recall status is terminated (terminated June 7, 2023). Affected quantity: 48 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- January 27, 2021
- Initiation Date
- March 19, 2020
- Termination Date
- June 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 syringes
Product Description
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 Pattern
Distributed Nationwide in the USA
Code Information
Lot # 02-2020-04@4