Infusion Options Recalls Granisetron Infusion Due to Sterility Concerns
Infusion Options, Inc. is recalling Granisetron 1000 mcg/50 mL NS infusion products 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 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a drug product where sterility is compromised (implying a risk of infection) falls under the 'Severe' category, as it represents a significant risk of harm even if specific hospitalization reports are not yet detailed in the provided text.
Plain-English summary
Infusion Options, Inc. is recalling Granisetron 1000 mcg / 50 mL NS, a prescription-only infusion product, due to a lack of assurance of sterility. The recall covers all lots within their expiry dates.
The affected products were distributed only in New York. 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, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients who have received or possess these products should contact Infusion Options, Inc. at 718-283-7233 for further instructions on how to return or dispose of the medication.
The recalled product
- Product
- GRANISETRON 1000 MCG / 50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
- Manufacturer
- Infusion Options, Inc.
- Category
- Drug — Infusion
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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