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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83050

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

Open FDA event record

Event summary

Timeline bucket
June 06, 2019
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Teva Pharmaceuticals USA

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

Complete imported group

Every recalled product in this event

2 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 2

LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00

D-1455-2019
Recall number
D-1455-2019
Initiated
June 06, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Teva Pharmaceuticals USA
Quantity
2,924,000 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

Arrow Malta (Teva) Bulk Product Lot # 1169752A, exp. date 01/2020, 1000 tablets/bottle 1169753A, exp. date 01/2020, 90 tablets/bottle Golden State Medical Finished Product Lot # GS017387, exp. date 01/2020 GS017651, exp. date 01/2020 GS017479, exp. date 01/2020

Distribution pattern

Nationwide by 4 major distributors.

drug · product 2 of 2

LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00

D-1456-2019
Recall number
D-1456-2019
Initiated
June 06, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Teva Pharmaceuticals USA
Quantity
2,943,000 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

Arrow Malta (Teva) Bulk Product Lot # 1163892A, exp. date 01/2020 1163893A, exp. date 01/2020 1163894A, exp. date 01/2020 1163895A, exp. date 01/2020 Golden State Medical Finished Product Lot # GS017042, exp. date 01/2020 GS017043, exp. date 01/2020 GS017044, exp. date 01/2020 GS017541, exp. date 01/2020

Distribution pattern

Nationwide by 4 major distributors.