The Recall Desk
ModerateFDA (Drugs)·D-0852-2016·Announced 2016-05-18

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.

What this means for you

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
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.

Same brand · BREVIBLOC