ERBITUX Infusions Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling ERBITUX 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in an intravenous medication, which is a significant risk of harm.
Plain-English summary
Infusion Options, Inc. is recalling specific lots of ERBITUX (770 mg/385 ml, 440 mg/220 ml, and 850 mg/425 ml) intravenous infusion bags. The recall is being conducted because of a lack of assurance of sterility. The affected products are prescription-only medications distributed exclusively in New York.
The recall covers all lots within their expiration dates. No specific lot numbers or dates are provided in the source text. The hazard is the potential presence of non-sterile conditions in the medication, which poses a risk to patients receiving the infusion.
Patients who have received these products should contact their healthcare provider for guidance. Infusion Options, Inc. is the recalling firm located in Brooklyn, NY.
The recalled product
- Product
- ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ 425 ml 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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