Infusion Options Recalls Rituxan Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Rituxan infusion bags 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 a drug product, which poses a significant risk of serious injury or death from infection.
Plain-English summary
Infusion Options, Inc. is recalling multiple lots of Rituxan (rituximab) intravenous infusion bags in various concentrations and volumes. The recall is being conducted because of a lack of assurance of sterility for the affected products.
The recalled products are distributed only in New York. The specific lots affected include all lots within their expiration dates. The products are prescription-only medications manufactured by Infusion Options, Inc., located in Brooklyn, New York.
Consumers and healthcare providers should stop using the affected Rituxan infusion bags and contact Infusion Options, Inc. or their healthcare provider for further instructions.
The recalled product
- Product
- RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL; RITUXAN 562 MG IN 562 ml 0.9% NACL; RITUXAN 700 MG QS 700 mL 0.9% NACL IVPB; RITUXAN 1000 MG / 350 mL 0.9% NACL IVPB RITUXAN 730 MG / 730 mL 0.9% NACL IVPB; RITUXAN 1000 MG QS 1000 ml NS; RITUXAN…
- 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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