June 2015 FDA Recall Rifampin by Fresenius Kabi Usa, Llc
D-1234-2015 - Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation

This Class II drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on June 4, 2015 for the product Rifampin. The FDA reported the reason for recall as failed impurities/degradation specifications; out-of-specification for color, impurity, and degradation. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1234-2015

Reason for Recall
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Initiated
06-04-2015
Reported
07-22-2015
Quantity
7,593 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71409
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi USA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide,Hawaii, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 6109469, 6109470, Exp 10/2016

Affected Packages Involved in this Recall

63323-351-20 Rifampin