Drug Enforcement D-0629-2024

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

Status

Ongoing

Classification

Class III

Report Date

August 14, 2024

Termination Date

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Product Information

Product description
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
Product quantity
12,624 bottles
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Amneal Pharmaceuticals, LLC
Address
400 Crossing Blvd Fl 3

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0629-2024
Event ID
95082
Recall initiation date
August 1, 2024
Center classification date
August 8, 2024
Code info
Lot # BB29124, Exp. 02/28/2026
More code info
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