June 2022 FDA Recall Losartan Potassium And Hydrochlorothiazide by Macleods Pharma Usa Inc
D-1164-2022 - CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
This Class II drug recall was voluntarily initiated by Macleods Pharma Usa Inc on June 10, 2022 for the product Losartan Potassium And Hydrochlorothiazide. The FDA reported the reason for recall as cgmp deviations- azido impurity levels observed to be above acceptable limits. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1164-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
06-10-2022
07-06-2022
84/1000 count bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Macleods Pharma Usa Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide.
05-23-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Batch or Lot Expiration Information
Lot# BLM2114A, exp. date 07/2023
