Home / Recalls / Macleods Pharma Usa Inc / D-0632-2022

D-0632-2022 Class II Terminated

Recalled by Macleods Pharma Usa Inc — Plainsboro, NJ

Recall Details

Product Type
Drugs
Report Date
March 9, 2022
Initiation Date
February 15, 2022
Termination Date
February 17, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,672 bottles

Product Description

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-192-07.

Reason for Recall

cGMP deviations

Distribution Pattern

USA Nationwide

Code Information

Lot#: BAD62101A, Exp 2/2024

Other recalls by Macleods Pharma Usa Inc

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  • 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-0835-2022 Class II — Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-coun (April 15, 2022)
  • D-0836-2022 Class II — Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count (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-0833-2022 Class II — Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07) (April 15, 2022)