Home / Recalls / Macleods Pharma Usa Inc / D-0838-2020

D-0838-2020 Class III Terminated

Recalled by Macleods Pharma Usa Inc — Plainsboro, NJ

Recall Details

Product Type
Drugs
Report Date
February 12, 2020
Initiation Date
January 24, 2020
Termination Date
December 16, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4694 30x60-count bottles

Product Description

Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09

Reason for Recall

Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.

Distribution Pattern

Nationwide

Code Information

Lot# BPA5903A, EXP 05/2021; BPA5819A, EXP 11/2020

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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-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)