FDAClass IAugust 14, 2013

Methotrexate Injection recall: Particulate Matter

Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ…

Why was Methotrexate Injection recalled?

Presence of Particulate Matter: Found during examination of retention samples.

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?

Lot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13

Product
Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ…
Recalling firm
Sandoz Incorporated
Quantity
1,635 vials
Distribution
Nationwide
Recall date
August 14, 2013
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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