The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1760-2019·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.

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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While no specific injuries are reported in the text, the lack of sterility assurance for IV chemotherapy agents poses a significant risk of serious infection, aligning with the Severe criteria for Class II recalls with potential for serious harm.

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, or 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 includes all lots within their expiration dates. The specific products include Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G, Cisplatin 80 MG / 250 ml 0.9% NACL, and other similar Cisplatin formulations.

Healthcare providers and patients should stop using these products and contact Infusion Options, Inc. for further instructions. The company is located at 5924 13th Ave, Brooklyn, NY 11219-4934, and can be reached at 718-283-7233.

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 — 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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