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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82037

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

Open FDA event record

Event summary

Timeline bucket
February 01, 2019
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

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

Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01

D-0484-2019
Recall number
D-0484-2019
Initiated
February 01, 2019
Classification
Class III
Status
Terminated
Quantity
43,860 3ml 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 Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.

Code information

Lot Numbers: H705562, H705563, EXP. 11/2019; H800616, EXP. 01/2020

Distribution pattern

Product was distributed by 5 wholesalers, 6 drug chains, 4 mail order pharmacies and 1 mail order pharmacy/supermarket who may have further distribute the product throughout the United States.