The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1808-2019·Announced 2019-08-21

Infusion Options Recalls Remicade Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling various Remicade infusion bags 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 severity score under the rubric for potential serious temporary or medically reversible health consequences.

Plain-English summary

Infusion Options, Inc. is recalling multiple presentations of Remicade (infliximab) in 250 mL 0.9% NaCl IV bags. The recall is being conducted because of a lack of assurance of sterility for the affected products.

The recalled products include Remicade in various concentrations, including 270 mg, 330 mg, 600 mg, 650 mg, 680 mg, 730 mg, 740 mg, 800 mg, and 1200 mg per 250 mL. The distribution was limited to New York. The recall covers all lots within their expiration dates.

Consumers and healthcare providers should stop using the affected Remicade infusions and contact Infusion Options, Inc. for further instructions or to return the product.

The recalled product

Product
REMICADE 680 MG QS 250 ML 0.9% NACL IVPB; REMICADE 270 MG QS 250 ML 0.9% NACL IV; REMICADE 730 MG QS 250 ML 0.9% NACL IVPB REMICADE 330 MG QS 250 ML 0.9% NACL IVPB; REMICADE 740 MG IN 250 ML NS IVPB; REMICADE 650 MG / 250 ml 0.9% NACL; REMICADE 1200 MG/250 ml 0.9% NACL IVPB…
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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