The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1790-2019·Announced 2019-08-21

Infusion Options Recalls Methotrexate Injections Due to Sterility Concerns

Infusion Options, Inc. is recalling various Methotrexate injection products in New York due to a lack of assurance of sterility.

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 FDA classified this as a Class II recall, and the rubric specifies that FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) fall under the 'Severe' category.

Plain-English summary

Infusion Options, Inc. is recalling multiple Methotrexate injection products, including intramuscular (IM) and intravenous (IV) formulations, due to a lack of assurance of sterility. The affected products include Methotrexate 25 mg/1 ml IM, 12 mg QS 5 ml, 98 mg/3.92 ml IM, 55 mg/2.2 ml IV, 59.5 mg/2.38 ml IV, 12 mg QS 6 ml, 150 mg/50 ml NS, and 112.5 mg/4.5 ml IM. These are prescription-only products manufactured by Infusion Options, Inc. in Brooklyn, New York.

The recall is limited to New York and includes all lots within their expiration dates. The FDA has classified this as a Class II recall, indicating that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Patients and healthcare providers should stop using the affected Methotrexate products and contact their healthcare provider for alternative treatment options. Infusion Options, Inc. is the recalling firm responsible for managing the recall.

The recalled product

Product
METHOTREXATE 25 MG / 1 ML IM SYR; METHOTREXATE 12 mg QS 5 ml PF 0.9% NACL; METHOTREXATE 98 MG / 3.92 ML IM SYR; METHOTREXATE 55 MG / 2.2 ML IVP; METHOTREXATE 59.5 MG / 2.38 ML IVP; METHOTREXATE 12 mg QS 6 ml 0.9% NACL; METHOTREXATE 150 MG / 50 ML NS IVPB; METHOTREXATE 112.5 MG…
Manufacturer
Infusion Options, Inc.
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 (1)

  • All lots within expiry

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 76 recalled by Infusion Options, 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 76 products in this recall →

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