Recalls / Class II
Class IID-0226-2021
Product
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
- Affected lot / code info
- Lot# 01-2020-28@10
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
- 71 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-03-19
- FDA classified
- 2021-01-12
- Posted by FDA
- 2021-01-20
- Terminated
- 2023-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0226-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.