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Class II: temporary or reversible health riskTerminated

Fresenius Kabi Rifampin for Injection Recall

Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresen…

Fresenius Kabi USA, LLC · Lake Zurich, IL

Risk level
Class II
Reported by FDA
Jul 22, 2015
Recall ID
D-1234-2015
Check your lot numberHow we source this data

Summary

Fresenius Kabi recalled Rifampin for Injection starting Jun 4, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1234-2015 on Jul 22, 2015. Reason: Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation

Product description

Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20

Lot numbers, UPCs & expiration codes

Lot #: 6109469, 6109470, Exp 10/2016

Where it was sold

Nationwide,Hawaii, 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-1234-2015
Classification
Class II
Status
Terminated
Recall initiated
Jun 4, 2015
FDA report date
Jul 22, 2015
Quantity
7,593 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Fresenius Kabi USA, LLC

Original FDA data

Every field from FDA enforcement report D-1234-2015, exactly as published.

Show all FDA fields
City
Lake Zurich
State
IL
Status
Terminated
Country
United States
Event ID
71409
Address
3 Corporate Dr
Code information
Lot #: 6109469, 6109470, Exp 10/2016
Postal code
60047-8930
Report date
Jul 22, 2015
Product type
Drugs
Recall number
D-1234-2015
Classification
Class II
Recalling firm
Fresenius Kabi USA, LLC
Product quantity
7,593 vials
Termination date
May 19, 2016
Reason for recall
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Voluntary / mandated
Voluntary: Firm initiated
Product description
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20
Distribution pattern
Nationwide,Hawaii, and Puerto Rico
Recall initiation date
Jun 4, 2015
Initial firm notification
Letter
Center classification date
Jul 14, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1234-2015, published Jul 22, 2015. View the source record (openFDA) · FDA enforcement reports

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

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