Home / Recalls / Macleods Pharma Usa Inc / D-0329-2021

D-0329-2021 Class III Terminated

Recalled by Macleods Pharma Usa Inc — Plainsboro, NJ

Recall Details

Product Type
Drugs
Report Date
April 21, 2021
Initiation Date
March 22, 2021
Termination Date
December 13, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8015 packs

Product Description

Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

Nationwide within the United States

Code Information

Lots # : ECD5908C, Exp 7/2021; ECD5909A, ECD5910A, ECD5911A, ECD5912A, Exp. 09/2021.

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-0837-2022 Class II — Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-cou (April 15, 2022)
  • D-0836-2022 Class II — Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count (April 15, 2022)
  • D-0833-2022 Class II — Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07) (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)