Macleods Pharma Usa Inc: Drug Recall

Recall #D-0762-2022 · 03/10/2022

Class III: Low Risk

Recall Details

Recall Number: D-0762-2022
Classification: Class III
Product Type: Drug
Recalling Firm: Macleods Pharma Usa Inc
Status: Terminated
Date Initiated: 03/10/2022
Location: Plainsboro, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4872 bottles

Reason for Recall

FAILED CONTENT UNIFORMITY SPECIFICATIONS

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.

Distribution Pattern

USA 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.