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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81168

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

Open FDA event record

Event summary

Timeline bucket
October 05, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
LUPIN SOMERSET

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

Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60

D-0092-2019
Recall number
D-0092-2019
Initiated
October 05, 2018
Classification
Class II
Status
Terminated
Recalling firm
LUPIN SOMERSET
Quantity
2712 60-ml 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 result noticed for total impurities observed during stability analysis

Code information

Lot# M16666, EXP 12/2018

Distribution pattern

Nationwide in the USA