The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1789-2019·Announced 2019-08-21

Infusion Options Recalls Leucovorin Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling various Leucovorin intravenous infusion bags due to a lack of assurance of sterility. The products were distributed in New York.

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, which corresponds to a Severe severity score (4) under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in intravenous products.

Plain-English summary

Infusion Options, Inc. is recalling multiple lots of Leucovorin intravenous infusion bags (IVPB) in various concentrations and volumes. The recall was initiated because of a lack of assurance of sterility for these products.

The affected products include Leucovorin formulations in Normal Saline (NS) and Dextrose 5% in Water (D5W) solutions. The specific products listed include concentrations ranging from 300 mg to 840 mg in 250 ml or 50 ml volumes, as well as other specific combinations such as 314 mg/50 ml and 324 mg/50 ml. All lots within their expiry dates are affected.

These products were distributed only in New York. Infusion Options, Inc. is the recalling firm. Consumers and healthcare providers should stop using these products and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG / 50 ml D5W IVPB; LEUCOVORIN 840 MG / 250 ml NS IVPB; LEUCOVORIN 750 MG / 250 ml NS IVPB; LEUCOVORIN 690 MG / 250 ml NS IVPB; LEUCOVORIN 314 mg / 50 ml NS IVPB; LEUCOVORIN 620 MG / 250 ml…
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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