The Recall Desk
SevereFDA (Drugs)·D-1793-2019·Announced 2019-08-21

Infusion Options Recalls Nivolumab IV Bags Due to Sterility Concerns

Infusion Options, Inc. is recalling Nivolumab IV bags 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 product, which poses a significant risk of serious injury or infection.

Plain-English summary

Infusion Options, Inc. is recalling Nivolumab 480 mg / 100 mL, 200 mg / 100 mL, 165 mg / 100 mL, and 240 mg / 100 mL IV bags. The recall is being conducted because of a lack of assurance of sterility.

The affected products are prescription-only infusion bags distributed in New York. All lots within the expiration date are included in this recall.

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

The recalled product

Product
NIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUMAB 165 mg / 100 ML NS IVPB; NIVOLUMAB 240 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 — Biologic / 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 →

Related recalls

Same manufacturer · Infusion Options, Inc.

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Same hazard · sterility

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