Home / Recalls / Macleods Pharma Usa Inc / D-1461-2019

D-1461-2019 Class II Terminated

Recalled by Macleods Pharma Usa Inc — Plainsboro, NJ

Recall Details

Product Type
Drugs
Report Date
July 17, 2019
Initiation Date
June 20, 2019
Termination Date
October 26, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
145162 bottles (13,064,580 tablets)

Product Description

Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-052-10

Reason for Recall

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Distribution Pattern

Nationwide

Code Information

BLM716A Jul-19 BLM717A Jul-19 BLM719A Aug-19 BLM720A Aug-19 BLM721A Sep-19 BLM722A Sep-19 BLM723A Oct-19 BLM724A Oct-19 BLM725A Oct-19 BLM726A Nov-19 BLM802A Dec-19 BLM803A Dec-19 BLM825A Sep-21 BLM826A Sep-21 BLM827A Sep-21

Other recalls by Macleods Pharma Usa Inc

  • D-0403-2026 Class II — Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufact (February 26, 2026)
  • D-0498-2024 Class II — Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-coun (May 7, 2024)
  • D-0162-2023 Class III — Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: M (January 5, 2023)
  • D-1174-2022 Class II — Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactu (June 16, 2022)
  • D-1164-2022 Class II — Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 cou (June 10, 2022)
  • D-0833-2022 Class II — Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07) (April 15, 2022)
  • D-0832-2022 Class II — Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10) (April 15, 2022)
  • D-0835-2022 Class II — Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-coun (April 15, 2022)
  • D-0834-2022 Class II — Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07 (April 15, 2022)
  • D-0837-2022 Class II — Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-cou (April 15, 2022)