Exact FDA event identifier

Event 95658

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: March 11, 2025
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

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

1 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 1

chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01

D-0309-2025

Recall number: D-0309-2025
Initiated: March 11, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Quantity: 8160 bottles

App-derived interpretation

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

N-Nitroso-Desmethyl Chlorpromazine 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: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.

Code information

Lot#s: 17232222 and 17232237, Exp 10/31/2025

Distribution pattern

Nationwide in the USA and PR