Exact FDA event identifier

Event 84674

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

Open FDA event record

Event summary

Timeline bucket: January 10, 2020
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Lupin 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

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

Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)

D-0790-2020

Recall number: D-0790-2020
Initiated: January 10, 2020
Classification: Class III
Status: Terminated
Recalling firm: Lupin Pharmaceuticals Inc.
Quantity: 34,080 boxes (3 wallets per carton, 80 cartons per box)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.

Code information

Lot # L800498, exp. date February 2020

Distribution pattern

Distributed nationwide in the US