January 2023 FDA Recall Drug by Macleods Pharma Usa, Inc (D-0162-2023 - Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.)

This Class III drug recall was voluntarily initiated by Macleods Pharma Usa, Inc on January 5, 2023 for the product Drug. The FDA reported the reason for recall as mismatching of the embossing on the tablets (t7) with the embossing mentioned in the package insert (ml63) in the distributed bottles.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0162-2023

Reason for Recall
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Initiated
01-05-2023
Reported
01-25-2023
Quantity
10052 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91441
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
MACLEODS PHARMA USA, INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within United States and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-24-2025
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : BLF2214A; Exp. 06/2025