The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1803-2019·Announced 2019-08-21

Infusion Options Recalls Pemetrexed Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling Pemetrexed infusion 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe; while no injuries are reported here, the 'lack of assurance of sterility' for an IV drug is a significant hazard that aligns with the Severe tier for Class II recalls where the risk is not theoretical but a failure of a critical safety attribute (sterility).

Plain-English summary

Infusion Options, Inc. is recalling specific Pemetrexed infusion products, including 910 mg, 940 mg, 1000 mg, 490 mg, and 800 mg concentrations, due to a lack of assurance of sterility. The affected products are prescription-only intravenous piggyback (IVPB) solutions distributed in New York.

The recall is classified as FDA Class II. The source text does not specify the exact number of units affected, specific lot numbers, or dates of distribution, noting only that all lots within expiry are included. No illnesses or injuries are reported in the source text.

Patients who have received these infusions should contact their healthcare provider for guidance. Infusion Options, Inc. is the recalling firm located in Brooklyn, New York.

The recalled product

Product
PEMETREXED 910 MG QS 100 ML NS IVPB; PEMETREXED 940 mg QS 100 ml NS IVPB; PEMETREXED 1000 mg QS 100 ml 0.9% NACL IVPB; PEMETREXED 490 MG /100 ml NS IVPB; PEMETREXED 800 mg/ 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — IV Infusion
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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