March 2019 FDA Recall Drug by Remedyrepack Inc. (D-1081-2019 - CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).)

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on March 14, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations; detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (api) - n-methylnitrosobutyric acid (nmba).. The product was distributed in Product was distributed to one sole customer, Miami, FL. and the recall is currently terminated.

Recall Number: D-1081-2019

Reason for Recall
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Initiated
03-14-2019
Reported
04-17-2019
Quantity
33 blister cards of 30 = 990 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82532
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 one sole customer, Miami, FL.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-11-2019
Product Description About Product Description
Full technical description of the product.
Losartan 50mg Tablet, 30 count each blister card.

Batch or Lot Expiration Information

Lot# 70518-0588-01
Lot# : J0328416-101518, Exp. Date: 10/2019