February 2019 FDA Recall Drug by Macleods Pharma Usa Inc
D-1040-2019 - CGMP Deviation
This Class II drug recall was voluntarily initiated by Macleods Pharma Usa Inc on February 21, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviation. The product was distributed in NJ, NY, FL and the recall is currently terminated.
Recall Number: D-1040-2019
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
02-21-2019
03-27-2019
9695 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.
NJ, NY, FL
09-28-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10
Batch or Lot Expiration Information
Lot# Lot BLM715A, Jul-19
