D-0226-2021 Class II Terminated
FDA drug recall D-0226-2021 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: 71 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- January 20, 2021
- Initiation Date
- March 19, 2020
- Termination Date
- June 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71 syringes
Product Description
Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505
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
Nationwide
Code Information
Lot# 01-2020-28@10