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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94606

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

Open FDA event record

Event summary

Timeline bucket
May 10, 2024
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Glenmark Pharmaceuticals Inc., 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

Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99

D-0532-2024
Recall number
D-0532-2024
Initiated
May 10, 2024
Classification
Class II
Status
Ongoing
Quantity
3,480 cartons

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Desmethyl Rizatriptan Impurity
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: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Code information

Lot#: 19233788; Exp. 9/2025 Lot#: 19224445; Exp. 9/2024

Distribution pattern

US Nationwide.

drug · product 2 of 2

Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99

D-0533-2024
Recall number
D-0533-2024
Initiated
May 10, 2024
Classification
Class II
Status
Ongoing
Quantity
11,976 cartons

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
N-Nitroso Desmethyl Rizatriptan Impurity
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: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Code information

Lot#: 19224217; Exp. 9/2024 Lot#: 19233789; Exp. 9/2025 Lot#: 19224444; Exp. 9/2024

Distribution pattern

US Nationwide.