The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1748-2019·Announced 2019-08-21

Infusion Options Recalls ALIMTA Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling ALIMTA 785 mg and 1000 mg intravenous infusion bags 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 agency classification is FDA Class II. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility in a medical product is classified as Severe (Score 4), particularly when it involves a high-risk hazard like potential infection, even without reported hospitalizations in the text.

Plain-English summary

Infusion Options, Inc. is recalling ALIMTA 785 mg QS 100 ml 0.9% NACL IVPB and ALIMTA 1000 mg QS 100 ml 0.9% NACL IVPB. The recall is being conducted because of a lack of assurance of sterility for the product.

The affected products are prescription-only intravenous infusion bags manufactured by Infusion Options, Inc. in Brooklyn, New York. The distribution was limited to New York, and the recall covers all lots within their expiration dates.

Patients who have received these infusions should contact their healthcare provider for guidance. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
ALIMTA 785 mg QS 100 ml 0.9% NACL IVPB; ALIMTA 1000 mg QS 100 ml 0.9% NACL IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — 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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