The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1795-2019·Announced 2019-08-21

Infusion Options Recalls OPDIVO Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling OPDIVO 200 mg and 480 mg infusion products in New York due to a lack of assurance of sterility.

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 source text identifies the agency classification as Class II. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility in an injectable drug is classified as Severe (Score 4).

Plain-English summary

Infusion Options, Inc. is recalling OPDIVO 200 mg/100 mL NS VPB and OPDIVO 480 mg/100 mL NS IVPB products. The recall is being conducted because of a lack of assurance of sterility. The affected products are prescription-only and were distributed in New York.

The recall includes all lots within their expiration dates. Infusion Options, Inc. is located in Brooklyn, New York. No specific lot numbers or dates are provided in the source text.

Patients who have received these products should contact their healthcare provider for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
OPDIVO 200 mg /100 ML NS VPB; OPDIVO 480 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 — Injectable 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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