Home / Recalls / Macleods Pharma Usa Inc / D-0833-2022

D-0833-2022 Class II Terminated

Recalled by Macleods Pharma Usa Inc — Plainsboro, NJ

Recall Details

Product Type
Drugs
Report Date
May 11, 2022
Initiation Date
April 15, 2022
Termination Date
October 13, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets

Product Description

Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Reason for Recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Distribution Pattern

Product was distributed nationwide.

Code Information

Lot # BLI2002A, exp. date 11/2022 BLI2004A, exp. date 11/2022 BLI2104B, exp. date 05/2023

Other recalls by Macleods Pharma Usa Inc

  • 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-0832-2022 Class II — Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10) (April 15, 2022)
  • D-0836-2022 Class II — Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count (April 15, 2022)
  • D-0837-2022 Class II — Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-cou (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-0835-2022 Class II — Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-coun (April 15, 2022)
  • D-0762-2022 Class III — Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured fo (March 10, 2022)