Home / Recalls / Macleods Pharma Usa Inc / D-0762-2022

D-0762-2022 Class III Terminated

Recalled by Macleods Pharma Usa Inc — Plainsboro, NJ

Recall Details

Product Type
Drugs
Report Date
April 13, 2022
Initiation Date
March 10, 2022
Termination Date
June 29, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4872 bottles

Product Description

Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07.

Reason for Recall

FAILED CONTENT UNIFORMITY SPECIFICATIONS

Distribution Pattern

USA Nationwide

Code Information

Lot #: BRD2001A, Exp 5/2022

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  • 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-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-0833-2022 Class II — Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07) (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)