April 2022 FDA Recall Drug by Remedyrepack Inc.
D-0788-2022 - CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on April 6, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations- azido impurity levels observed to be above acceptable limits.. The product was distributed in Product was distributed to customers in AK and PA. and the recall is currently terminated.

Recall Number: D-0788-2022

Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Initiated
04-06-2022
Reported
05-04-2022
Quantity
433/30 count blister cards, 33/60 count blister cards

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89968
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to customers in AK and PA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-27-2022
Product Description About Product Description
Full technical description of the product.
Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.

Batch or Lot Expiration Information

Lot# B1467803-120621, exp. date 06/30/2022
Lot# J0585793-121721, exp. date 12/31/2022