Adcetris IV Infusion Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling Adcetris 96 mg/100 mL IV infusion bags due to a lack of assurance of sterility. The product was distributed in New York.
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 involves a lack of assurance of sterility, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Infusion Options, Inc. is recalling Adcetris 96 MG/100 ML NS IVPB, a prescription-only intravenous infusion product. The recall was initiated because of a lack of assurance of sterility. The product is manufactured by Infusion Options, Inc., located in Brooklyn, New York.
The recall affects all lots within their expiration dates. The distribution pattern for this recall is limited to New York. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. No specific illness or injury counts are provided in the source text.
The recalled product
- Product
- Adcetris 96 MG/100 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
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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