April 2019 FDA Recall Drug by Remedyrepack Inc.
D-1270-2019 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on April 22, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to Florida. and the recall is currently terminated.

Recall Number: D-1270-2019

Reason for Recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Initiated
04-22-2019
Reported
05-08-2019
Quantity
44 HDPE bottles of 90 = 3,960 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82748
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 Florida.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2020
Product Description About Product Description
Full technical description of the product.
Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.

Batch or Lot Expiration Information

Lot# : B0517068-101618, Exp. Date: 10/2019