FDA recall D-0629-2024

Amneal Pharmaceuticals, LLC · Class III · drug

Product

Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1

Reason for recall

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

Distribution

Nationwide in the USA

Key facts

Status
Completed
Initiation date
2024-08-01
Report date
2024-08-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0629-2024