MACLEODS PHARMA USA, INC: Drug Recall

Recall #D-0498-2024 · 05/07/2024

Class II: Risk

Recall Details

Recall Number: D-0498-2024
Classification: Class II
Product Type: Drug
Recalling Firm: MACLEODS PHARMA USA, INC
Status: Ongoing
Date Initiated: 05/07/2024
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,048 bottles

Reason for Recall

Presence of foreign substance: plastic-like substance.

Product Description

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44

Distribution Pattern

USA Nationwide

Other Recalls by MACLEODS PHARMA USA, INC

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
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.