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Class II: temporary or reversible health riskTerminated

Baxter Healthcare Brevibloc DOUBLE STRENGTH Premixed Injection Recall

Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride,…

Baxter Healthcare Corp. · Deerfield, IL

Risk level
Class II
Reported by FDA
May 18, 2016
Recall ID
D-0852-2016
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled Brevibloc DOUBLE STRENGTH Premixed Injection starting Apr 12, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0852-2016 on May 18, 2016. Reason: Discoloration: presence of atypical yellow discoloration of the solution . Status: Terminated.

Why it was recalled

Discoloration: presence of atypical yellow discoloration of the solution .

Product description

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

Lot numbers, UPCs & expiration codes

Lot # C989954, Exp 9/17

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0852-2016
Classification
Class II
Status
Terminated
Recall initiated
Apr 12, 2016
FDA report date
May 18, 2016
Quantity
11,630 babs
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corp.

Original FDA data

Every field from FDA enforcement report D-0852-2016, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Terminated
Country
United States
Event ID
73812
Address
1 Baxter Pkwy
Code information
Lot # C989954, Exp 9/17
Postal code
60015-4625
Report date
May 18, 2016
Product type
Drugs
Recall number
D-0852-2016
Classification
Class II
Recalling firm
Baxter Healthcare Corp.
Product quantity
11,630 babs
Termination date
Mar 20, 2017
Reason for recall
Discoloration: presence of atypical yellow discoloration of the solution .
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide
Recall initiation date
Apr 12, 2016
Initial firm notification
Letter
Center classification date
May 12, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0852-2016, published May 18, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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