Pembrolizumab Infusion Recalled Due to Lack of Sterility Assurance
Infusion Options, Inc. is recalling Pembrolizumab 200 mg/100 mL IV 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 and involves a lack of sterility assurance for an intravenous product, which poses a significant risk of serious injury or hospitalization, meeting the criteria for a Severe rating.
Plain-English summary
Infusion Options, Inc. is recalling Pembrolizumab 200 mg / 100 mL NS IVPB, a prescription-only intravenous infusion product. The recall is being conducted because of a lack of assurance of sterility. The product is distributed in New York only, and all lots within their expiry dates are affected.
This recall is classified as Class II by the U.S. Food and Drug Administration. The specific hazard identified is the potential for the product to not be sterile, which poses a risk to patients receiving the infusion. No specific illness or injury counts are provided in the source text.
Patients who have received this product should contact their healthcare provider for further guidance. The recalling firm is Infusion Options, Inc., located in Brooklyn, New York.
The recalled product
- Product
- PEMBROLIZUMAB 200 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 — Biologic / 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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