March 2020 FDA Recall Drug by Edge Pharma, Llc
D-0226-2021 - Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.

This Class II drug recall was voluntarily initiated by Edge Pharma, Llc on March 19, 2020 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; the media used to conduct post-compounding sterility testing for the methotrexate product was expired.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0226-2021

Reason for Recall
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Initiated
03-19-2020
Reported
01-20-2021
Quantity
71 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87115
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Edge Pharma, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-07-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 01-2020-28@10