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.
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 3/5 (High).
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.
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