The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1799-2019·Announced 2019-08-21

Infusion Options Recalls Paclitaxel Albumin Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling Paclitaxel Albumin infusions 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, and the hazard involves a lack of assurance of sterility in a drug product, which aligns with the criteria for a Severe rating (FDA Class II with potential for significant injury).

Plain-English summary

Infusion Options, Inc. is recalling multiple concentrations of Paclitaxel Albumin infusions (145 mg, 150 mg, 160 mg, 165 mg, and 185 mg per 100 ml) in New York. The recall is being conducted because of a lack of assurance of sterility for the affected products.

The affected products are prescription-only intravenous piggyback (IVPB) solutions. The recall covers all lots within their expiration dates. The distribution was limited to New York.

Healthcare providers and patients should stop using the affected products and contact Infusion Options, Inc. for further instructions or to return the product.

The recalled product

Product
PACLITAXEL ALBUMIN 185 mg /100 ml NS IVPB; PACLITAXEL ALBUMIN 160 MG / 100 ml NS IVPB; PACLITAXEL ALBUMIN 145 MG / 100 ml NS IVPB PACLITAXEL ALBUMIN 165 mg / 100 ml NS IVPB; PACLITAXEL ALBUMIN 150 mg /100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY…
Manufacturer
Infusion Options, Inc.
Category
Drug — Chemical
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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