FDA Recalls Bivalirudin Injectable Drug Due to Particulate Matter
Accord Healthcare is recalling Bivalirudin for Injection lot M2212070 due to the presence of fiber particles. Bivalirudin is an injectable blood thinner used in cardiac procedures.
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: FDA Class II recall for particulate contamination in an injectable anticoagulant with no reported illnesses, injuries, or deaths. Particulate matter in injectables represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Accord Healthcare, Inc. is recalling Bivalirudin for Injection, 250 mg, due to the presence of particulate matter identified as fiber. The affected lot is M2212070 with an expiration date of August 2024. Approximately 1,680 vials were distributed nationwide in the United States.
Bivalirudin is an injectable anticoagulant (blood thinner) administered intravenously during certain cardiac procedures. The presence of fiber particles in injectable medications poses a potential safety risk to patients.
Patients and healthcare providers who have this recalled lot should stop using it and contact Accord Healthcare, Inc. or their healthcare provider for guidance on alternative medications or next steps.
The recalled product
- Product
- BIVALIRUDIN (BIVALIRUDIN)
- Brand
- BIVALIRUDIN
- Manufacturer
- Accord Healthcare, Inc.
- Hazard
- Affected units
- 1,680
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)
- Lot #: M2212070 Exp. date 08/2024
UPCs (1)
- 0316729275033
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Accord Healthcare, 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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