The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1681-2012·Announced 2012-09-26

Hospira Recalls Methotrexate Injection Due to Embedded Glass Particles

Hospira Inc. is recalling Methotrexate Injection vials because visible particles embedded in the glass neck may dislodge into the solution.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (embedded glass particles) in a cytotoxic drug, which poses a significant risk of injury if particles dislodge into the solution.

Plain-English summary

Hospira Inc. is recalling Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vials. The recall affects 34,572 vials with lot number Y064457AA and an expiration date of October 2013. The product was distributed nationwide, including Puerto Rico and Guam, as well as internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand, and Vietnam.

The recall was initiated due to visible particles embedded in the glass located at the neck of the vial. There is a potential for the product to come into contact with these embedded particles, which may become dislodged into the solution. This recall is classified as FDA Class II.

Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions. The recall also includes other affected lots of Carboplatin Injection, Cytarabine Injection, and Paclitaxel Injection due to the same defect.

The recalled product

Product
METHOTREXATE (METHOTREXATE)
Brand
METHOTREXATE
Manufacturer
Hospira Inc.
Category
Drug — Antineoplastic
Hazard
Affected units
34,572

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 (4)

  • lot number Y064457AA
  • exp OCT 2013 Rest of world lot numbers: list M4457A001
  • lot number Y054457AB
  • exp SEP 2013

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same brand · METHOTREXATE

Same manufacturer · Hospira Inc.

See all →

Same hazard · glass particles

See all →

Similar recalls