MACLEODS PHARMA USA, INC: Drug Recall

Recall #D-0162-2023 · 01/05/2023

Class III: Low Risk

Recall Details

Recall Number: D-0162-2023
Classification: Class III
Product Type: Drug
Recalling Firm: MACLEODS PHARMA USA, INC
Status: Terminated
Date Initiated: 01/05/2023
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10052 bottles

Reason for Recall

Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

Product Description

Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08

Distribution Pattern

Nationwide within United States and Puerto Rico.

Other Recalls by MACLEODS PHARMA USA, INC

Class II: Risk 05/07/2024

Presence of foreign substance: plastic-like substance.
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.