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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90415

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

Open FDA event record

Event summary

Timeline bucket
June 10, 2022
Product types
Drug
Classifications
Class II
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

Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16

D-1150-2022
Recall number
D-1150-2022
Initiated
June 10, 2022
Classification
Class II
Status
Terminated
Quantity
3,216 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 test results observed in dissolution testing during long term stability study.

Code information

Lots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22

Distribution pattern

Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.