The Recall Desk
HighFDA (Drugs)·D-1806-2019·Announced 2019-08-21

Infusion Options Recalls Preservative-Free Sodium Chloride Syringes Due to Sterility Concerns

Infusion Options, Inc. is recalling preservative-free 0.9% sodium chloride 5 mL syringes in New York due to a lack of assurance of sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (lack of sterility) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Infusion Options, Inc. is recalling preservative-free 0.9% sodium chloride 5 mL syringes. The recall was initiated because of a lack of assurance of sterility for the product.

The affected product is prescription-only and was distributed in New York. The recall covers all lots within their expiration dates.

Consumers and healthcare providers should stop using the recalled syringes and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
PRESERVATIVE FREE 0.9% NACL 5 ML SYR, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — Sodium Chloride Injection
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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