DARATUMUMAB infusion products recalled due to lack of assurance of sterility
The FDA is recalling DARATUMUMAB infusion solutions because sterility cannot be assured, creating a potential infection risk.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as High because it involves a risk-of-harm product (sterile injectable medications) where no injuries or illnesses have been reported yet, consistent with the rubric's definition for High severity.
Plain-English summary
The FDA is recalling DARATUMUMAB 904 MG and DARATUMUMAB 668 MG IVPB infusion solutions manufactured by Infusion Options, Inc. These products, distributed in New York, are subject to recall because there is a lack of assurance of sterility. This sterility concern represents a risk of infection if the products are administered without proper sterilization verification. Consumers should follow their healthcare provider's guidance and dispose of any remaining product according to local regulations. The recall covers all lots within expiry and applies specifically to New York distribution.
The recalled product
- Product
- DARATUMUMAB 904 MG QS 500 ML NS IVPB; DARATUMUMAB 668 MG QS 1000 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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