March 2019 FDA Recall Drug by Direct Rx
D-0032-2021 - CGMP deviation

This Class II drug recall was voluntarily initiated by Direct Rx on March 12, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviation. The product was distributed in FL and the recall is currently terminated.

Recall Number: D-0032-2021

Reason for Recall
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Initiated
03-12-2019
Reported
10-07-2020
Quantity
33 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86487
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.
Direct Rx
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.
FL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-21-2021
Product Description About Product Description
Full technical description of the product.
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90

Batch or Lot Expiration Information

Lot# Lot: 12DE1806 Exp. 01/31/2021