Home / Recalls / MACLEODS PHARMA USA, INC / D-0162-2023

D-0162-2023 Class III Terminated

Recalled by MACLEODS PHARMA USA, INC — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
January 25, 2023
Initiation Date
January 5, 2023
Termination Date
June 24, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10052 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

Reason for Recall

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

Distribution Pattern

Nationwide within United States and Puerto Rico.

Code Information

Lot #: BLF2214A; Exp. 06/2025

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  • D-0835-2022 Class II — Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-coun (April 15, 2022)
  • D-0762-2022 Class III — Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured fo (March 10, 2022)