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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80377

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

Open FDA event record

Event summary

Timeline bucket
June 28, 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

Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11

D-0927-2018
Recall number
D-0927-2018
Initiated
June 28, 2018
Classification
Class II
Status
Terminated
Recalling firm
LUPIN SOMERSET
Quantity
3456 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug and Failed Content Uniformity.

Code information

Lot#: S700065, Exp. 02/2019; 700619, Exp. 08/2019

Distribution pattern

Nationwide within the US