April 2019 FDA Recall Drug by Preferred Pharmaceuticals, Inc
D-1281-2019 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc on April 30, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in CA, GA, IN. No DOD/VA accounts. No foreign accounts. and the recall is currently terminated.

Recall Number: D-1281-2019

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 at the manufacturer
Initiated
04-30-2019
Reported
05-22-2019
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82791
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.
Preferred 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, GA, IN. No DOD/VA accounts. No foreign accounts.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-03-2023
Product Description About Product Description
Full technical description of the product.
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ

Batch or Lot Expiration Information

Lot# a) 30 tablets: lot A1818G batch 01181807 exp 3/2020; b) 90 tablets: lot L0517L batch 12051712 exp 3/2020