Infliximab Infusion Bags Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling Infliximab 300 mg/250 mL infusion bags due to a lack of assurance of sterility. The recall affects 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric. The hazard involves a lack of sterility assurance for an intravenous product, posing a significant risk of infection.
Plain-English summary
Infusion Options, Inc. is recalling Infliximab 300 mg / 250 mL 0.9% NACL IVPB, a prescription-only intravenous infusion product. The recall was initiated because of a lack of assurance of sterility. The product is distributed in New York only.
The recall covers all lots within their expiration dates. Infliximab is a biologic medication typically used to treat inflammatory conditions. The specific risk associated with the lack of sterility assurance is the potential for contamination, which could lead to infection if the product is administered.
Patients who have received this product should contact their healthcare provider for guidance. Healthcare facilities should stop using the recalled product and contact the recalling firm for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- InFLIXimab 300 mg / 250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
- Manufacturer
- Infusion Options, Inc.
- Category
- Drug — Biologic 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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