Exact FDA event identifier

Event 80377

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

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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