The Recall Desk
SevereFDA (Drugs)·D-1759-2019·Announced 2019-08-21

Infusion Options Recalls Cisplatin Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling various Cisplatin infusion products due to a lack of assurance of sterility. The recall is limited to New York.

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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from non-sterile medical products.

Plain-English summary

Infusion Options, Inc. is recalling multiple lots of Cisplatin infusion products, including various concentrations and volumes mixed with normal saline, 0.9% NACL, and Mannitol. The recall is issued because of a lack of assurance of sterility for these products.

The affected products are prescription-only (Rx Only) and were distributed only in New York. The recall covers all lots within their expiry dates. No specific lot numbers, dates, or unit counts are provided in the source text.

Consumers and healthcare providers should stop using the affected products and contact Infusion Options, Inc. for further instructions.

The recalled product

Product
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 44 MG QS 500 ml NS IVPB; Cisplatin 40 MG / 500 ml 0.9% NACL; Cisplatin 36 MG / 500 ML NS IVPB; Cisplatin 73 MG QS 500 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 70 MG / 500 ml NS
Manufacturer
Infusion Options, Inc.
Category
Drug — Infusion Therapy
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 · infection

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