Infusion Options Recalls ORENCIA Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling ORENCIA 750 mg IV infusions 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 an intravenous product, which poses a significant risk of serious injury or infection.
Plain-English summary
Infusion Options, Inc. is recalling ORENCIA 750 mg QS 100 ml 0.9% NACL IVPB, a prescription-only intravenous infusion product. The recall is being conducted because of a lack of assurance of sterility.
The affected product is distributed in New York only. 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 affected product and contact Infusion Options, Inc. for further instructions.
The recalled product
- Product
- ORENCIA 750 mg QS 100 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.
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