FDAClass IIJune 2, 2021

Methotrexate Injection recall: CGMP Deviations

Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, Inc. Lake Forest, IL 60045. NDC 61703-350-38.

Why was Methotrexate Injection recalled?

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

H074437AA

Product
Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, Inc. Lake Forest, IL 60045. NDC 61703-350-38.
Recalling firm
Cardinal Health Inc.
Quantity
341 vials
Distribution
FL, GA, SC
Recall date
June 2, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls