The Recall Desk
SevereFDA (Drugs)·D-1807-2019·Announced 2019-08-21

Infusion Options Recalls Ramucirumab Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling specific Ramucirumab infusion products 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile medical products.

Plain-English summary

Infusion Options, Inc. is recalling Ramucirumab 457 mg and 1182 mg infusion products. The recall is being conducted because of a lack of assurance of sterility for these products.

The affected products are distributed in New York only. The recall covers all lots within their expiration dates.

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

The recalled product

Product
RAMUCIRUMAB 457 MG QS 250 ML NS IVPB; AMUCIRUMAB 1182 MG QS 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 — 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 · lack of sterility

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