Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated
FDA Recall NDC 33342-050
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 8 recorded enforcement report(s) associated with Losartan Potassium And Hydrochlorothiazide (NDC 33342-050). A significant event, classified as Class II, was initiated on May 07, 2024 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "Presence of foreign substance: plastic-like substance."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of foreign substance: plastic-like substance.
May 07, 2024
May 22, 2024
1,048 bottles
Recall Profile & Regulatory Data
Event ID
94592
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
MACLEODS PHARMA USA, INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44
Batch or Lot Expiration Information
Lot# : BLK2304A, Exp. 07/31/2025
Affected Packages Involved in this Recall
33342-050-07Product
33342-050-10Product
33342-050-44Product
33342-050-12Product
33342-051-07Product
33342-051-10Product
33342-051-44Product
33342-051-12Product
33342-052-07Product
33342-052-10Product
33342-052-44Product
33342-052-12Product
June 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
Jun 10, 2022
Jul 06, 2022
84/1000 count bottles
Recall Profile & Regulatory Data
Event ID
90426
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
May 23, 2024
Product Description
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Batch or Lot Expiration Information
Lot# BLM2114A, exp. date 07/2023
Affected Packages Involved in this Recall
33342-050-07Product
33342-050-10Product
33342-050-44Product
33342-050-12Product
33342-051-07Product
33342-051-10Product
33342-051-44Product
33342-051-12Product
33342-052-07Product
33342-052-10Product
33342-052-44Product
33342-052-12Product
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
N/A
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 & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Batch or Lot Expiration Information
Lot# BLM2106B, exp. date 05/2023 BLM2101A, exp. date 01/2025 BLM2102A, exp. date 02/2023 BLM2106A, exp. date 05/2023 BLM2103B, exp. date 02/2023 BLM2104A, exp. date 05/2023 BLM2110A, exp. date 06/2023
Affected Packages Involved in this Recall
33342-050-07Product
33342-050-10Product
33342-050-44Product
33342-050-12Product
33342-051-07Product
33342-051-10Product
33342-051-44Product
33342-051-12Product
33342-052-07Product
33342-052-10Product
33342-052-44Product
33342-052-12Product
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
N/A
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 & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Batch or Lot Expiration Information
Lot# BLK2107B, exp. date 05/2023 BLK2101A, exp. date 01/2025 BLK2102A, exp. date 02/2025 BLK2103B, exp. date 02/2023 BLK2103C, exp. date 02/2023 BLK2104A, exp. date 05/2023
Affected Packages Involved in this Recall
33342-050-07Product
33342-050-10Product
33342-050-44Product
33342-050-12Product
33342-051-07Product
33342-051-10Product
33342-051-44Product
33342-051-12Product
33342-052-07Product
33342-052-10Product
33342-052-44Product
33342-052-12Product
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
N/A
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 & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Batch or Lot Expiration Information
Lot# BLL2107B, exp. date 05/2023 BLL2101A, exp. date 01/2025 BLL2102A, exp. date 02/2025 BLL2103B, exp. date 02/2023 BLL2104A, exp. date 05/2023
Affected Packages Involved in this Recall
33342-050-07Product
33342-050-10Product
33342-050-44Product
33342-050-12Product
33342-051-07Product
33342-051-10Product
33342-051-44Product
33342-051-12Product
33342-052-07Product
33342-052-10Product
33342-052-44Product
33342-052-12Product
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
29106 bottles (2,619,540 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 and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-051-10
Batch or Lot Expiration Information
Lot# BLL801A Dec-19 BLL802A Dec-19 BLL803A Dec-19
Affected Packages Involved in this Recall
33342-050-07Product
33342-050-10Product
33342-050-44Product
33342-050-12Product
33342-051-07Product
33342-051-10Product
33342-051-44Product
33342-051-12Product
33342-052-07Product
33342-052-10Product
33342-052-44Product
33342-052-12Product
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
142626 bottles (12,836,340 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 and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-10
Batch or Lot Expiration Information
Lot# BLK719A Sep-19 BLK720A Sep-19 BLK721A Sep-19 BLK722A Sep-19 BLK723A Sep-19 BLK724A Sep-19 BLK725A Oct-19 BLK726A Oct-19 BLK804A Jan-20 BLK806A Jan-20 BLK825A Oct-21 BLK826A Oct-21
Affected Packages Involved in this Recall
33342-050-07Product
33342-050-10Product
33342-050-44Product
33342-050-12Product
33342-051-07Product
33342-051-10Product
33342-051-44Product
33342-051-12Product
33342-052-07Product
33342-052-10Product
33342-052-44Product
33342-052-12Product
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
145162 bottles (13,064,580 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 andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-052-10
Batch or Lot Expiration Information
Lot# BLM716A Jul-19 BLM717A Jul-19 BLM719A Aug-19 BLM720A Aug-19 BLM721A Sep-19 BLM722A Sep-19 BLM723A Oct-19 BLM724A Oct-19 BLM725A Oct-19 BLM726A Nov-19 BLM802A Dec-19 BLM803A Dec-19 BLM825A Sep-21 BLM826A Sep-21 BLM827A Sep-21
Affected Packages Involved in this Recall
33342-050-07Product
33342-050-10Product
33342-050-44Product
33342-050-12Product
33342-051-07Product
33342-051-10Product
33342-051-44Product
33342-051-12Product
33342-052-07Product
33342-052-10Product
33342-052-44Product
33342-052-12Product
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.
