Exact FDA event identifier

Event 83151

5 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: June 20, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Macleods Pharma Usa Inc

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 5

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

D-1457-2019

Recall number: D-1457-2019
Initiated: June 20, 2019
Classification: Class II
Status: Terminated
Recalling firm: Macleods Pharma Usa Inc
Quantity: 47520 bottles (4,276,800 tablets)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Code information

BLI711A Nov 2019

Distribution pattern

Nationwide

drug · product 2 of 5

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

D-1458-2019

Recall number: D-1458-2019
Initiated: June 20, 2019
Classification: Class II
Status: Terminated
Recalling firm: Macleods Pharma Usa Inc
Quantity: 4277 bottles (4,277,000 tablets)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Code information

BLI710A Nov 2019

Distribution pattern

Nationwide

drug · product 3 of 5

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

D-1459-2019

Recall number: D-1459-2019
Initiated: June 20, 2019
Classification: Class II
Status: Terminated
Recalling firm: Macleods Pharma Usa Inc
Quantity: 142626 bottles (12,836,340 tablets)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Code information

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

Distribution pattern

Nationwide

drug · product 4 of 5

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

D-1460-2019

Recall number: D-1460-2019
Initiated: June 20, 2019
Classification: Class II
Status: Terminated
Recalling firm: Macleods Pharma Usa Inc
Quantity: 29106 bottles (2,619,540 tablets)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Code information

BLL801A Dec-19 BLL802A Dec-19 BLL803A Dec-19

Distribution pattern

Nationwide

drug · product 5 of 5

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

D-1461-2019

Recall number: D-1461-2019
Initiated: June 20, 2019
Classification: Class II
Status: Terminated
Recalling firm: Macleods Pharma Usa Inc
Quantity: 145162 bottles (13,064,580 tablets)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Code information

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

Distribution pattern

Nationwide