Exact FDA event identifier

Event 82782

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

Event summary

Timeline bucket: May 03, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Heritage Pharmaceuticals, 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 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-10

D-1287-2019

Recall number: D-1287-2019
Initiated: May 03, 2019
Classification: Class II
Status: Terminated
Recalling firm: Heritage Pharmaceuticals, Inc.
Quantity: 3012 bottles

App-derived interpretation

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

impurity, N-Methylnitrosobutyric 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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Code information

Lot CLO17007A Lot CLO17008A Lot CLO17009A ; Exp 11/2019

Distribution pattern

Nationwide

drug · product 2 of 5

Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-09

D-1288-2019

Recall number: D-1288-2019
Initiated: May 03, 2019
Classification: Class II
Status: Terminated
Recalling firm: Heritage Pharmaceuticals, Inc.
Quantity: 25220 bottles

App-derived interpretation

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

impurity, N-Methylnitrosobutyric 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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Code information

Lot CLO17012A exp 11/2019 Lot CLO17013A exp 11/2019 Lot CLO18002A exp 01/2020 Lot CLO18020A exp 04/2020 Lot CLO18021A exp 04/2020 Lot CLO18022A exp 04/2020

Distribution pattern

Nationwide

drug · product 3 of 5

Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-09

D-1289-2019

Recall number: D-1289-2019
Initiated: May 03, 2019
Classification: Class II
Status: Terminated
Recalling firm: Heritage Pharmaceuticals, Inc.
Quantity: 34403 bottles

App-derived interpretation

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

impurity, N-Methylnitrosobutyric 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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Code information

Lot CLO17009B exp 11/2019 Lot CLO17010A exp 11/2019 Lot CLO18023A exp 04/2020

Distribution pattern

Nationwide

drug · product 4 of 5

Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-10

D-1290-2019

Recall number: D-1290-2019
Initiated: May 03, 2019
Classification: Class II
Status: Terminated
Recalling firm: Heritage Pharmaceuticals, Inc.
Quantity: 3697 bottles

App-derived interpretation

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

impurity, N-Methylnitrosobutyric 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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Code information

CLO17014A exp 12/2019 CLO17015A exp 01/2020 CLO17016A exp 01/2020 CLO17017A exp 01/2020 CLO18001A exp 01/2020 CLO18002B exp 01/2020

Distribution pattern

Nationwide

drug · product 5 of 5

Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-644-09

D-1291-2019

Recall number: D-1291-2019
Initiated: May 03, 2019
Classification: Class II
Status: Terminated
Recalling firm: Heritage Pharmaceuticals, Inc.
Quantity: 15541 bottles

App-derived interpretation

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

impurity, N-Methylnitrosobutyric 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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Code information

Lot CLO17006A exp 11/2019

Distribution pattern

Nationwide