Infusion Options Recalls Methotrexate Injections Due to Sterility Concerns

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/ 4

Manufacturer

Infusion Options, Inc.

Category

Drug — Injectable

Hazard

• sterility
• infection

Is your product affected?

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

Distribution

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