Infusion Options Recalls Decitabine Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Decitabine 40 mg/100 ml infusions 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or infection.
Plain-English summary
Infusion Options, Inc. is recalling Decitabine 40 mg / 100 ml NS IVPB, a prescription-only intravenous infusion product. The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product is distributed only in New York. The recall covers all lots within their expiration dates. No specific lot numbers or dates are provided in the source text.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- DECITABINE 40 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
- Manufacturer
- Infusion Options, Inc.
- Category
- Drug — IV 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.
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