September 2023 FDA Recall Methotrexate Sodium by West-ward Columbus Inc
D-0066-2024 - Failed Tablet/Capsule Specifications
This Class III drug recall was voluntarily initiated by West-ward Columbus Inc on September 22, 2023 for the product Methotrexate Sodium. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed in MS, OH and the recall is currently ongoing.
Recall Number: D-0066-2024
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
09-22-2023
11-01-2023
2,673 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
West-Ward Columbus Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MS, OH
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot AB7486B, exp Dec 2023; Lot AB8766B, exp April 2024; Lot AB9484B, exp Aug 2024
