Infusion Options Recalls Cytarabine Products Due to Sterility Concerns
Infusion Options, Inc. is recalling Cytarabine 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in injectable medications, which poses a significant risk of infection or serious injury.
Plain-English summary
Infusion Options, Inc. is recalling specific Cytarabine products, including Cytarabine 128 MG/250 ML D5W IVPB, Cytarabine 20 MG / 1 ML SQ SYRINGE, Cytarabine 70 MG QS 6 ML PF NS SYRINGE, and Cytarabine 100 MG QS 3 ML PF NS SYRINGE. The recall is being conducted because of a lack of assurance of sterility.
The affected products are prescription-only medications distributed in New York. The recall covers all lots within their expiration dates. Infusion Options, Inc. is the recalling firm located in Brooklyn, New York.
Patients and healthcare providers should stop using these products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Cytarabine 128 MG/250 ML D5W IVPB; Cytarabine 20 MG / 1 ML SQ SYRINGE Cytarabine 70 MG QS 6 ML PF NS SYRINGE; Cytarabine 100 MG QS 3 ML PF NS SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
- Manufacturer
- Infusion Options, Inc.
- Category
- Drug — Antineoplastic
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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