Infusion Options Recalls DARZALEX Infusion Bags Due to Sterility Concerns
Infusion Options, Inc. is recalling DARZALEX 1008 mg / 500 mL IV 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an IV product corresponds to a severity score of 4 (Severe), as it may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Infusion Options, Inc. is recalling DARZALEX 1008 mg / 500 mL NS IVPB, a prescription-only intravenous infusion product. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is distributed in New York only. All lots within the expiration date are included in this recall. The product is manufactured by Infusion Options, Inc., located in Brooklyn, New York.
Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DARZALEX 1008 MG / 500 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
- Manufacturer
- Infusion Options, Inc.
- Category
- Drug — IV 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.
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