FDA Recall Methotrexate Sodium

The most recent Recall Enforcement Report that covers this product was initiated on September 22nd, 2023 and classified as a Class III recall due to failed tablet/capsule specifications: tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring. This recall is currently ongoing, and the associated recall number is recall number is D-0066-2024. It pertains to Methotrexate Sodium identified by 0054-8550.

Recall Number D-0066-2024

Event ID

93223 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).

Recall Number

D-0066-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).

Recall Classification

Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".

Distribution Pattern

MS, OH What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.

Product Description

Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25

Reason For Recall

Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring. What is the Reason for Recall?
Information describing how the product is defective.

Product Quantity

2,673 cartons Product Quantity
The amount of product subject to recall.

Voluntary Mandated

Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.

Report Date

11-01-2023

Recall Initiation Date

09-22-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.

Initial Firm Notification

Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.

Product Type

Drugs

Recalling Firm

West-Ward Columbus Inc

Code Info/dt>

Lot, expiry: Lot AB7486B, exp Dec 2023; Lot AB8766B, exp April 2024; Lot AB9484B, exp Aug 2024 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.

Recalled NDC Packages

0054-4550-25; 0054-4550-15; 0054-8550-25

Status

Ongoing

View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.