Baxter Recalls Brevibloc Injection Due to Yellow Discoloration
Baxter Healthcare is recalling Brevibloc (esmolol hydrochloride) injection because the solution shows atypical yellow discoloration. The recall covers 11,630 units distributed nationwide.
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. The hazard is a visual defect (discoloration) with no reported illnesses or injuries, fitting the criteria for a moderate severity recall involving potential quality issues.
Plain-English summary
Baxter Healthcare Corporation is recalling Brevibloc (esmolol hydrochloride) Double Strength Premixed Injection, 2000mg/100mL (20 mg/mL), 100 mL. The recall is due to the presence of atypical yellow discoloration in the solution. The affected product is identified by Lot # C989954 with an expiration date of 9/17.
The recall involves 11,630 units of the product, which were distributed nationwide. Brevibloc is a prescription-only intravenous medication manufactured by Baxter Healthcare Corporation in Deerfield, Illinois.
Healthcare providers and patients should stop using the affected lots of Brevibloc and contact Baxter Healthcare for further instructions or to arrange for the return of the product.
The recalled product
- Product
- BREVIBLOC (ESMOLOL HYDROCHLORIDE)
- Brand
- BREVIBLOC
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Prescription Injection
- Affected units
- 11,630
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 # C989954
- Exp 9/17
Distribution
Distributed nationwide across the United States.
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