The Recall Desk
SevereFDA (Drugs)·D-1782-2019·Announced 2019-08-21

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.

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 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
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 · sterility

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