The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1772-2019·Announced 2019-08-21

Infusion Options Recalls Durvalumab Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling Durvalumab infusions 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property-damage reports or high-risk contamination.

Plain-English summary

Infusion Options, Inc. is recalling Durvalumab 651 mg/250 ml NS IVPB and Durvalumab 650 mg/250 ml NS IVPB. The recall was initiated because of a lack of assurance of sterility for the affected products.

The recalled products are prescription-only infusions distributed in New York. All lots within their expiration dates are included in this recall.

Consumers and healthcare providers should stop using the recalled products and contact Infusion Options, Inc. at 718-283-7233 for further instructions.

The recalled product

Product
Durvalumab 651 mg/ 250 ml NS IVPB; Durvalumab 650 mg/ 250 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 →

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