Baxter Recalls Brevibloc Injection Due to Particulate Matter
Baxter Healthcare is recalling Brevibloc (esmolol hydrochloride) injection due to complaints of discolored solution and subvisible iron oxide particles.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Baxter Healthcare Corp. is recalling 20,810 containers of Brevibloc (esmolol hydrochloride) Premixed Injection. The product is an intravenous prescription drug packaged in 250 mL Single Use IntraVia containers. The recall covers Lot # C926923 with an expiration date of 01/16.
The recall was initiated due to complaints identifying a discolored solution containing subvisible particles of iron oxide that are agglomerating. This particulate matter was found in the product.
The affected product was distributed nationwide. Healthcare providers and patients should stop using the recalled product and contact Baxter Healthcare or their local FDA office for further instructions.
The recalled product
- Product
- BREVIBLOC (ESMOLOL HYDROCHLORIDE)
- Brand
- BREVIBLOC
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Prescription Injection
- Affected units
- 20,810
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 (2)
- Lot #: C926923
- Exp 01/16
Distribution
Distributed nationwide across the United States.
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