The Recall Desk
SevereFDA (Drugs)·D-1800-2019·Announced 2019-08-21

Infusion Options Recalls Paclitaxel Protein Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling specific paclitaxel protein infusion products in New York due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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 an intravenous drug, which poses a significant risk of serious injury or hospitalization.

Plain-English summary

Infusion Options, Inc. is recalling specific lots of Paclitaxel Protein 175 mg/100 mL, 190 mg/100 mL, and 355 mg/100 mL NS IVPB. The recall is being conducted because of a lack of assurance of sterility for these products.

The affected products are prescription-only and were distributed exclusively in New York. The recall covers all lots within their expiration dates.

Consumers and healthcare providers should stop using the recalled products and contact Infusion Options, Inc. at 718-283-7233 for further instructions.

The recalled product

Product
PACLITAXEL PROTEIN 175 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 190 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 355 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 — Antineoplastic
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 →

Related recalls

Same manufacturer · Infusion Options, Inc.

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Same hazard · sterility

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