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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81925

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

Open FDA event record

Event summary

Timeline bucket
January 15, 2019
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 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.

D-0390-2019
Recall number
D-0390-2019
Initiated
January 15, 2019
Classification
Class II
Status
Terminated
Recalling firm
LUPIN SOMERSET
Quantity
24,180 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 October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.

Code information

Lot #: S700214, Exp Apr-19; S700447, Exp Jun-19; S700787, Exp Oct-19; S701057, Exp Nov-19; S800107, Exp Feb-20; S800266, Exp Mar-20; S800524, Exp May-20; S800791, Exp Jul-20

Distribution pattern

Nationwide in the USA and Puerto Rico

Field note

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