Macleods Pharma Usa Inc: Drug Recall

Recall #D-0329-2021 · 03/22/2021

Class III: Low Risk

Recall Details

Recall Number: D-0329-2021
Classification: Class III
Product Type: Drug
Recalling Firm: Macleods Pharma Usa Inc
Status: Terminated
Date Initiated: 03/22/2021
Location: Plainsboro, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8015 packs

Reason for Recall

Failed Impurities/Degradation Specifications

Product Description

Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10

Distribution Pattern

Nationwide within the United States

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.