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Class II: temporary or reversible health riskTerminated

Fresenius Kabi Midazolam Hydrochloride Injection Recall

MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only

Fresenius Kabi USA, LLC · Lake Zurich, IL

Risk level
Class II
Reported by FDA
Dec 17, 2014
Recall ID
D-0295-2015
Check your lot numberHow we source this data

Summary

Fresenius Kabi recalled Midazolam Hydrochloride Injection starting Sep 27, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0295-2015 on Dec 17, 2014. Reason: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

Product description

MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.

Lot numbers, UPCs & expiration codes

Lot 6003827, Exp. Date 04/2015

Where it was sold

U.S. Nationwide Including 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-0295-2015
Classification
Class II
Status
Terminated
Recall initiated
Sep 27, 2012
FDA report date
Dec 17, 2014
Quantity
101,200 Vials
Recall type
Voluntary: Firm initiated
Recalling firm
Fresenius Kabi USA, LLC

Original FDA data

Every field from FDA enforcement report D-0295-2015, exactly as published.

Show all FDA fields
City
Lake Zurich
State
IL
Status
Terminated
Country
United States
Event ID
63451
Address
3 Corporate Dr
Code information
Lot 6003827, Exp. Date 04/2015
Postal code
60047-8930
Report date
Dec 17, 2014
Product type
Drugs
Recall number
D-0295-2015
Classification
Class II
Recalling firm
Fresenius Kabi USA, LLC
Product quantity
101,200 Vials
Termination date
Dec 12, 2014
Reason for recall
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Voluntary / mandated
Voluntary: Firm initiated
Product description
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.
Distribution pattern
U.S. Nationwide Including Puerto Rico
Recall initiation date
Sep 27, 2012
Initial firm notification
Letter
Center classification date
Dec 10, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0295-2015, published Dec 17, 2014. 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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