Macleods Pharma Usa Inc: Drug Recall

Recall #D-0833-2022 · 04/15/2022

Class II: Risk

Recall Details

Recall Number: D-0833-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Macleods Pharma Usa Inc
Status: Terminated
Date Initiated: 04/15/2022
Location: Plainsboro, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets

Reason for Recall

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

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

Distribution Pattern

Product was distributed nationwide.

Other Recalls by Macleods Pharma Usa Inc

Class II: Risk 05/07/2024

Presence of foreign substance: plastic-like substance.
Class III: Low Risk 01/05/2023

Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class II: Risk 06/16/2022

Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Class II: Risk 06/10/2022

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II: Risk 04/15/2022

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

View all recalls by Macleods Pharma Usa Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.