Exact FDA event identifier

Event 77606

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

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Event summary

Timeline bucket: June 22, 2017
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

Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06

D-0974-2017

Recall number: D-0974-2017
Initiated: June 22, 2017
Classification: Class III
Status: Terminated
Recalling firm: Lupin Pharmaceuticals Inc.
Quantity: 12480 bottles

App-derived interpretation

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

Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.

Code information

Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019

Distribution pattern

Nationwide in the USA