The Recall Desk
HighFDA (Drugs)·D-1769-2019·Announced 2019-08-21

Infusion Options Recalls Docetaxel Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling various Docetaxel infusion bags in New York due to a lack of assurance of sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

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 poses a risk of harm even without reported injuries.

Plain-English summary

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

The affected products include Docetaxel 60 mg, 71 mg, 155 mg, 110 mg, 150 mg, 137 mg, 130 mg, 140 mg, 144 mg, 117 mg, 30 mg, 125 mg, and 135 mg per 250 ml, mixed with D5W or Normal Saline. The recall is limited to New York, and all lots within their expiration dates are affected.

Healthcare providers and patients should contact Infusion Options, Inc. for further information regarding the recall and proper disposal or replacement of the affected products.

The recalled product

Product
DOCETAXEL 60 MG / 250 ml D5W IVPB; DOCETAXEL 71 MG/ 250 ML NS IVPB; DOCETAXEL 155 MG/ 250 ml NS IVPB; DOCETAXEL 110 mg / 250 ml NS IVPB; DOCETAXEL 150 MG / 250 ml NS IVPB; DOCETAXEL 137 mg / 250 ml 0.9% NACL IVPB; DOCETAXEL 130 MG/ 250 ml NS IVPB; DOCETAXEL 140 MG/ 250 ml NS IVPB
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

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Same hazard · sterility

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