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Class II: temporary or reversible health riskTerminated

Fresenius Kabi Midazolam Injection Recall

MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx…

Fresenius Kabi USA, LLC · Lake Zurich, IL

Risk level
Class II
Reported by FDA
Feb 8, 2017
Recall ID
D-0456-2017
Check your lot numberHow we source this data

Summary

Fresenius Kabi recalled Midazolam Injection starting Dec 16, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0456-2017 on Feb 8, 2017. Reason: Failed Impurities/Degradation Specifications. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05

Lot numbers, UPCs & expiration codes

Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017

Where it was sold

Nationwide and Puerto Rico

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-0456-2017
Classification
Class II
Status
Terminated
Recall initiated
Dec 16, 2016
FDA report date
Feb 8, 2017
Quantity
47, 020 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Fresenius Kabi USA, LLC

Original FDA data

Every field from FDA enforcement report D-0456-2017, exactly as published.

Show all FDA fields
City
Lake Zurich
State
IL
Status
Terminated
Country
United States
Event ID
76001
Address
3 Corporate Dr
Code information
Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017
Postal code
60047-8930
Report date
Feb 8, 2017
Product type
Drugs
Recall number
D-0456-2017
Classification
Class II
Recalling firm
Fresenius Kabi USA, LLC
Product quantity
47, 020 vials
Termination date
Jun 22, 2018
Reason for recall
Failed Impurities/Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Dec 16, 2016
Initial firm notification
Letter
Center classification date
Feb 2, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0456-2017, published Feb 8, 2017. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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