October 2019 FDA Recall Rifampin by Mylan Laboratories Limited (sterile Products Division) (D-0139-2020 - Failed Impurities/Degradation Specifications)

This Class II drug recall was voluntarily initiated by Mylan Laboratories Limited (sterile Products Division) on October 7, 2019 for the product Rifampin. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0139-2020

Reason for Recall
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Initiated
10-07-2019
Reported
10-16-2019
Quantity
19,165 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83914
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.
Mylan Laboratories Limited (Sterile Products Division)
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 in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-09-2023
Product Description About Product Description
Full technical description of the product.
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.

Batch or Lot Expiration Information

Lot# Lot: 7008334, Exp April 2020; 7008417, Exp Oct 2020

Affected Packages Involved in this Recall

67457-445-60 Rifampin