December 2022 FDA Recall Drug by Remedyrepack Inc.
D-0098-2023 - Failed Impurities/Degradation specifications

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on December 20, 2022 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Product was distributed to one account in PA. and the recall is currently terminated.

Recall Number: D-0098-2023

Reason for Recall
Failed Impurities/Degradation specifications
Initiated
12-20-2022
Reported
01-18-2023
Quantity
132 Cards of 30 = 3960 Tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91345
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.
RemedyRepack 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.
Product was distributed to one account in PA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-03-2023
Product Description About Product Description
Full technical description of the product.
Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.

Batch or Lot Expiration Information

Lot# : J0599794-022322, exp. date 02/28/2023; J0621369-052622, exp. date 06/30/2023