December 2022 FDA Recall Rifampin by Lupin Pharmaceuticals Inc.
D-0100-2023 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on December 12, 2022 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-0100-2023

Reason for Recall
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Initiated
12-12-2022
Reported
01-18-2023
Quantity
16,056 30 count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91295
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.
Lupin Pharmaceuticals Inc.
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.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-31-2024
Product Description About Product Description
Full technical description of the product.
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06

Batch or Lot Expiration Information

Lot# A200171, Exp 12/2023

Affected Packages Involved in this Recall

68180-658-06 Rifampin
68180-658-01 Rifampin
68180-659-06 Rifampin
68180-659-07 Rifampin
68180-659-01 Rifampin