Infusion Options Recalls Oxytocin IV Solution Due to Sterility Concerns
Infusion Options, Inc. is recalling Oxytocin 60 units/1000 mL Lactated Ringers IV Solution because the product lacks assurance of sterility. The recall affects 820 bags distributed in New York.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility in an intravenous product is classified as Severe (Score 4), particularly given the potential for serious injury from non-sterile IV fluids.
Plain-English summary
Infusion Options, Inc. is recalling Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, a prescription-only medication. The recall was initiated because the product lacks assurance of sterility. The affected product consists of 820 bags, each containing 60 units of Oxytocin in 1000 mL of Lactated Ringers solution.
The recall covers all lots within their expiration dates. The product was distributed only in New York. Infusion Options, Inc. is the recalling firm and the manufacturer of the product.
Healthcare providers and patients who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
- Manufacturer
- Infusion Options, Inc.
- Category
- Drug — Intravenous Solution
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
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