The Recall Desk
CriticalFDA (Drugs)·D-1328-2015·Announced 2015-08-19

Methotrexate Injection Recalled Due to Presence of Particulate Matter

Mylan Institutional LLC is recalling Methotrexate Injection vials due to the presence of particulate matter.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which is defined as a situation where use of or exposure to a violative product may cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 5.

Plain-English summary

Mylan Institutional LLC is recalling Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vials. The recall is being conducted because of the presence of particulate matter in the product.

The affected product is distributed by Pfizer Labs, Division of Pfizer Inc., and manufactured for Mylan Institutional LLC. The recall covers specific lots: Lot 7801082 (Exp. 07/15) and Lot 7801421 (Exp. 09/16). The distribution pattern is nationwide and Puerto Rico.

Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be quarantined and not administered. Patients who have received the affected product should contact their healthcare provider for guidance.

The recalled product

Product
Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Ro
Manufacturer
Mylan Institutional LLC
Category
Drug — Injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot #: a) 7801082
  • Exp. 07/15 and b) 7801421
  • Exp. 09/16

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

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Same hazard · particulate matter

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