Why it was recalled
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
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
Lot numbers, UPCs & expiration codes
Lot# 01-2020-28@10
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0226-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 19, 2020
- FDA report date
- Jan 20, 2021
- Quantity
- 71 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Edge Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0226-2021, exactly as published.
Show all FDA fields
- City
- Colchester
- State
- VT
- Status
- Terminated
- Country
- United States
- Event ID
- 87115
- Address
- 856 Hercules Dr
- Code information
- Lot# 01-2020-28@10
- Postal code
- 05446-8014
- Report date
- Jan 20, 2021
- Product type
- Drugs
- Recall number
- D-0226-2021
- Classification
- Class II
- Recalling firm
- Edge Pharma, LLC
- Product quantity
- 71 syringes
- Termination date
- Jun 7, 2023
- Reason for recall
- Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 19, 2020
- Initial firm notification
- Letter
- Center classification date
- Jan 12, 2021