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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82249

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

Open FDA event record

Event summary

Timeline bucket
February 26, 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 bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.

D-0517-2019
Recall number
D-0517-2019
Initiated
February 26, 2019
Classification
Class III
Status
Terminated
Quantity
674,628 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: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.

Code information

Lots: H701618, H701619, H701620, Exp March 2019; H702220, H702221, H702222, H702223, H702224, H702225, H702351, Exp April 2019; H702971, H702972, H702973, H702974, H703151, H703152, H703153, Exp June 2019; H703155, H703682, H703683, Exp July 2019; H704243, H704245, H704247, Exp September 2019; H704707, H704709, H705038, H705039, Exp October 2019; H705561, Exp November 2019; H800394, H800395, H800617, H800618, Exp January 2020; H801585, H801586, H801721, H801722, Exp March 2020; H802138, H802139, H802140, Exp April 2020; H802421, H802707, H802718, Exp May 2020; H803187, H803188, H803232, Exp June 2020; H803749, H803750, Exp July 2020; H804326, H804327, H804328, H804330, H804549, H804552, H804630, H804632, Exp September 2020; H805163, H805361, H805362, H805676, Exp November 2020; H805690, H805692, H805694, Exp December 2020

Distribution pattern

Nationwide in the USA and Puerto Rico.