Exact FDA event identifier

Event 78697

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

Event summary

Timeline bucket: December 04, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Solco Healtcare US LLC

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

Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50

D-0155-2018

Recall number: D-0155-2018
Initiated: December 04, 2017
Classification: Class II
Status: Terminated
Recalling firm: Solco Healtcare US LLC
Quantity: N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Mix-Up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg

Code information

Lot # 7700656A

Distribution pattern

Product was distributed in Mason, OH.