GAZYVA Infusion Recall Due to Lack of Sterility Assurance
Infusion Options, Inc. is recalling GAZYVA 100 mg and 900 mg infusion 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, which corresponds to a 'Severe' severity score per the rubric, particularly given the risk of infection associated with a lack of sterility assurance in an intravenous product.
Plain-English summary
Infusion Options, Inc. is recalling GAZYVA 100 mg in 250 mL Normal Saline IVPB and GAZYVA 900 mg in 250 mL Normal Saline IVPB. The recall is being conducted because of a lack of assurance of sterility for these prescription-only infusion products.
The affected products were 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 products and contact Infusion Options, Inc. at 718-283-7233 for further instructions.
The recalled product
- Product
- GAZYVA 100 MG IN 250 ML NS IVPB; GAZYVA 900 MG IN 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
- Manufacturer
- Infusion Options, Inc.
- Category
- Drug — Infusion
- Hazard
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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