Exact FDA event identifier

Event 83875

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

Event summary

Timeline bucket: September 23, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Sandoz, 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

3 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 3

Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60

D-0127-2020

Recall number: D-0127-2020
Initiated: September 23, 2019
Classification: Class II
Status: Terminated
Recalling firm: Sandoz, Inc
Quantity: 100,314 bottles

App-derived interpretation

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

impurity, N-nitrosodimethylamine (NDMA

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: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

Code information

HC9266 4/30/2020 HD1865 4/30/2020 HP9441 9/30/2020 JK7994 8/31/2021 JK8659 8/31/2021

Distribution pattern

U.S. Nationwide

drug · product 2 of 3

Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05

D-0128-2020

Recall number: D-0128-2020
Initiated: September 23, 2019
Classification: Class II
Status: Terminated
Recalling firm: Sandoz, Inc
Quantity: 13,130 bottles

App-derived interpretation

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

impurity, N-nitrosodimethylamine (NDMA

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: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

Code information

HD1862 4/30/2020 HP9438 9/30/2020 HP9439 9/30/2020 HP9440 9/30/2020

Distribution pattern

U.S. Nationwide

drug · product 3 of 3

Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31

D-0129-2020

Recall number: D-0129-2020
Initiated: September 23, 2019
Classification: Class II
Status: Terminated
Recalling firm: Sandoz, Inc
Quantity: 136,788 bottles

App-derived interpretation

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

impurity, N-nitrosodimethylamine (NDMA

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: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

Code information

HD8625 4/30/2020 HD9275 4/30/2020 HU2207 8/31/2020 HX6676 3/31/2021 HX6677 3/31/2021

Distribution pattern

U.S. Nationwide