The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1773-2019·Announced 2019-08-21

Entyvio Infusion Recalled for Lack of Sterility Assurance

Infusion Options, Inc. is recalling Entyvio 300 mg/250 mL due to a lack of assurance of sterility. The product was distributed in 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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues) are categorized as Severe.

Plain-English summary

Infusion Options, Inc. is recalling Entyvio 300 mg/250 mL 0.9% NaCl, a prescription-only infusion product. The recall is being conducted because of a lack of assurance of sterility. The product was distributed in New York only.

The recall covers all lots within their expiration dates. 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.

Consumers and healthcare providers who have this product should stop using it and contact Infusion Options, Inc. at 718-283-7233 for further instructions.

The recalled product

Product
ENTYVIO 300 MG /250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — 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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