The Recall Desk
SevereFDA (Drugs)·D-1812-2019·Announced 2019-08-21

Infusion Options Recalls IV Fluids Due to Sterility Concerns

Infusion Options, Inc. is recalling specific IV fluid 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 severity score under the rubric for significant injury or property damage risks, specifically involving a lack of sterility assurance for an intravenous product.

Plain-English summary

Infusion Options, Inc. is recalling Sodium Chloride 0.9% 1 LITER WITH Potassium Chloride 20 mEq, Mannitol 12.5 G, and Magnesium Sulfate 2 G. The recall is being conducted because of a lack of assurance of sterility for the affected products.

The affected products are prescription-only (Rx Only) and were distributed in New York. 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 or to return the products.

The recalled product

Product
Sodium Chloride 0.9% 1 LITER WITH Potassium Chloride 20 mEq, Mannitol 12.5 G, Magnesium Sulfate 2 G, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

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 →