The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1797-2019·Announced 2019-08-21

Infusion Options Recalls Oxaliplatin Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling multiple lots of oxaliplatin infusion bags 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, which corresponds to a Severe severity score under the rubric. The hazard involves a lack of assurance of sterility in a parenteral drug, which poses a significant risk of infection.

Plain-English summary

Infusion Options, Inc. is recalling multiple lots of oxaliplatin infusion bags in various concentrations and volumes. The recall is being conducted due to a lack of assurance of sterility. The affected products are prescription-only intravenous piggyback (IVPB) solutions in D5W.

The recall is limited to New York. All lots within their expiration dates are affected. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.

Healthcare providers and patients should stop using the affected oxaliplatin infusion bags and contact Infusion Options, Inc. for further instructions. The company can be reached at 718-283-7233.

The recalled product

Product
OXALIPLATIN 145 MG /250 ML D5W IVPB; OXALIPLATIN 154 MG / 250 ML D5W IVPB; OXALIPLATIN 130 MG / 250 ML D5W IVPB; OXALIPLATIN 140 MG / 250 ml D5W IVPB; OXALIPLATIN 162 MG / 250 ML D5W IVPB; OXALIPLATIN 169 MG / 250 ML D5W IVPB; OXALIPLATIN 90 MG / 500 ML D5W IVPB; OXALIPLATIN 50…
Manufacturer
Infusion Options, Inc.
Category
Drug — Oncology 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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