August 2018 FDA Recall Drug by Remedyrepack Inc.
D-1146-2018 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on August 20, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in South Carolina and the recall is currently terminated.

Recall Number: D-1146-2018

Reason for Recall
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Initiated
08-20-2018
Reported
09-05-2018
Quantity
3 bottles of 90 tablets (270 tablets overall)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80891
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
South Carolina
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-10-2018
Product Description About Product Description
Full technical description of the product.
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0

Batch or Lot Expiration Information

Lot# 70518-1220-0
Lot# : B0476653-080218; Exp. Date: 08/2019