The Recall Desk
SevereFDA (Drugs)·D-1786-2019·Announced 2019-08-21

Infusion Options Recalls Injectafer IV Products Due to Sterility Concerns

Infusion Options, Inc. is recalling Injectafer 720 mg and 210 mg IV 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 and involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.

Plain-English summary

Infusion Options, Inc. is recalling Injectafer 720 mg in 100 ml NS IVPB and Injectafer 210 mg in 100 ml NS IVPB. The recall is being conducted because of a lack of assurance of sterility for these prescription-only infusion products.

The affected products were distributed in New York. The recall covers all lots within their expiration dates. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using these products and contact Infusion Options, Inc. at 718-283-7233 for further instructions on how to return or dispose of the recalled items.

The recalled product

Product
INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 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 — IV 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 · sterility

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