Losartan Potassium Tablet, Film Coated
FDA Recall NDC 33342-044
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Losartan Potassium (NDC 33342-044). A significant event, classified as Class II, was initiated on Apr 15, 2022 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
April 2022 Class II Recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall Number
Class II Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Apr 15, 2022
May 11, 2022
12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets
Recall Profile & Regulatory Data
Event ID
90037
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide.
Termination Date
Oct 13, 2023
Product Description
Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Batch or Lot Expiration Information
Lot# BLH2002A, exp. date 11/2022 BLH2003B, exp. date 11/2022 BLH2004A, exp. date 11/2022
Affected Packages Involved in this Recall
33342-044-10Product
33342-044-12Product
33342-044-07Product
33342-044-44Product
33342-045-10Product
33342-045-12Product
33342-045-07Product
33342-045-44Product
33342-046-10Product
33342-046-12Product
33342-046-07Product
33342-046-44Product
April 2022 Class II Recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall Number
Class II Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Apr 15, 2022
May 11, 2022
3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets
Recall Profile & Regulatory Data
Event ID
90037
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide.
Termination Date
Oct 13, 2023
Product Description
Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Batch or Lot Expiration Information
Lot# BLI2107B, exp. date 06/2023 BLI2101A, exp. date 12/2022 BLI2103A, exp. date 12/2022 BLI2105A, exp. date 05/2023
Affected Packages Involved in this Recall
33342-044-10Product
33342-044-12Product
33342-044-07Product
33342-044-44Product
33342-045-10Product
33342-045-12Product
33342-045-07Product
33342-045-44Product
33342-046-10Product
33342-046-12Product
33342-046-07Product
33342-046-44Product
April 2022 Class II Recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall Number
Class II Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Apr 15, 2022
May 11, 2022
3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets
Recall Profile & Regulatory Data
Event ID
90037
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide.
Termination Date
Oct 13, 2023
Product Description
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Batch or Lot Expiration Information
Lot# BLI2002A, exp. date 11/2022 BLI2004A, exp. date 11/2022 BLI2104B, exp. date 05/2023
Affected Packages Involved in this Recall
33342-044-10Product
33342-044-12Product
33342-044-07Product
33342-044-44Product
33342-045-10Product
33342-045-12Product
33342-045-07Product
33342-045-44Product
33342-046-10Product
33342-046-12Product
33342-046-07Product
33342-046-44Product
Class II Terminated
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Jun 20, 2019
Jul 17, 2019
47520 bottles (4,276,800 tablets)
Recall Profile & Regulatory Data
Event ID
83151
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 26, 2021
Product Description
Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10
Batch or Lot Expiration Information
Lot# BLI711A Nov 2019
Affected Packages Involved in this Recall
33342-044-10Product
33342-044-12Product
33342-044-07Product
33342-044-44Product
33342-045-10Product
33342-045-12Product
33342-045-07Product
33342-045-44Product
33342-046-10Product
33342-046-12Product
33342-046-07Product
33342-046-44Product
Class II Terminated
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Jun 20, 2019
Jul 17, 2019
4277 bottles (4,277,000 tablets)
Recall Profile & Regulatory Data
Event ID
83151
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 26, 2021
Product Description
Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44
Batch or Lot Expiration Information
Lot# BLI710A Nov 2019
Affected Packages Involved in this Recall
33342-044-10Product
33342-044-12Product
33342-044-07Product
33342-044-44Product
33342-045-10Product
33342-045-12Product
33342-045-07Product
33342-045-44Product
33342-046-10Product
33342-046-12Product
33342-046-07Product
33342-046-44Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
