April 2019 FDA Recall Drug by Legacy Pharmaceutical Packaging Llc
D-1263-2019 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Legacy Pharmaceutical Packaging Llc on April 24, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in TN, AZ and the recall is currently ongoing.

Recall Number: D-1263-2019

Reason for Recall
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Initiated
04-24-2019
Reported
05-08-2019
Quantity
60,012 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82710
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Legacy Pharmaceutical Packaging LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TN, AZ
Product Description About Product Description
Full technical description of the product.
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54

Batch or Lot Expiration Information

Lot# Lot 181598; 02/2021