Class II · Moderate risk
Esmolol HCl 100 mg/10 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Brevibloc DOUBLE STRENGTH Premixed Injection (Esmolol Hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Discoloration: presence of atypical yellow discoloration of the solution .
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87
Affected NDC
10019-0075-87
Compare with the code on your package — it is the most precise check available.
Drug: Esmolol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Brevibloc Esmolol Hydrochloride NDC 10019-0075 |
20 mg/mL | Injection Intravenous |
Baxter Healthcare Company | Rx |
- Recalling firm
- Baxter Healthcare Corp.
- NDC code
- 10019-075-87
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0852-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Esmolol recalls
See all
Class II · Moderate risk
Esmolol HCl Injectable Solution 100 mg/10 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Esmolol HCl in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Esmolol HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Brevibloc Premixed Injection
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Other recalls by Baxter Healthcare Corp.
All 2016 recalls
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
Class II · Moderate risk
Daptomycin
CGMP Deviations
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
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