MACLEODS PHARMA USA, INC

FDA Regulatory Profile

Summary

Total Recalls
33
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0498-2024Class IILosartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, MMay 7, 2024
D-0162-2023Class IIILevofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, January 5, 2023
D-1174-2022Class IIEszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods PhJune 16, 2022
D-1164-2022Class IILosartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-June 10, 2022
D-0835-2022Class IILosartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 3334April 15, 2022
D-0832-2022Class IILosartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottApril 15, 2022
D-0833-2022Class IILosartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottleApril 15, 2022
D-0836-2022Class IILosartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342April 15, 2022
D-0837-2022Class IILosartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 333April 15, 2022
D-0834-2022Class IILosartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottlApril 15, 2022
D-0762-2022Class IIIRisedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma UMarch 10, 2022
D-0639-2022Class IIOlanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , InFebruary 16, 2022
D-0632-2022Class IIAmlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured fFebruary 15, 2022
D-0078-2022Class IIIRizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) BOctober 18, 2021
D-0079-2022Class IIIRizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) BlisterOctober 18, 2021
D-0080-2022Class IIIRizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) BlisteOctober 18, 2021
D-0787-2021Class IIClopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, IAugust 2, 2021
D-0329-2021Class IIICandesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods PharMarch 22, 2021
D-0838-2020Class IIIPioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, ManufaJanuary 24, 2020
D-0823-2020Class IIIMontelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods PhJanuary 20, 2020