The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1798-2019·Announced 2019-08-21

Infusion Options Recalls Paclitaxel Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling various Paclitaxel 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the 'lack of assurance of sterility' for an IV chemotherapy drug represents a significant risk of serious infection, aligning with the Severe category for high-risk medical products where the defect is structural/process-related rather than minor labeling.

Plain-English summary

Infusion Options, Inc. is recalling multiple lots of Paclitaxel intravenous infusion bags (IVPB) in various concentrations and volumes. The recall is being conducted because of a lack of assurance of sterility in the products.

The affected products are distributed in New York only. The specific products include Paclitaxel in Normal Saline (NS), Sodium Chloride 0.9% (NACL), and Dextrose 5% in Water (D5W) solutions, with concentrations ranging from 80 mg to 385 mg per 250 ml or 500 ml. All lots within their expiry dates are included in this recall.

Patients who have received these infusions should contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
PACLITAXEL 258 MG / 500 ML NS IVPB; PACLITAXEL 318 MG / 500 ML NS IVPB; PACLITAXEL 385 MG / 500 ML NS IVPB; PACLITAXEL 340 MG / 500 ML NS IVPB; PACLITAXEL 332 MG / 500 ML NS IVPB; PACLITAXEL 250 MG / 500 ML NS IVPB; PACLITAXEL 117 MG / 250 ML NACL 0.9% IVPB PACLITAXEL 90 MG…
Manufacturer
Infusion Options, Inc.
Category
Drug — Chemotherapy 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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