Exact FDA event identifier

Event 74086

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

Event summary

Timeline bucket: May 05, 2016
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: KVK-Tech, Inc.

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

Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03

D-1057-2016

Recall number: D-1057-2016
Initiated: May 05, 2016
Classification: Class III
Status: Terminated
Recalling firm: KVK-Tech, Inc.
Quantity: 9360 bottles of lot # 12825A and 7284 bottles of lot # 12937A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Discoloration: presence of scuffing marks on tablets.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration: presence of scuffing marks on tablets.

Code information

Lot #: 12825 A, 12937A, Exp 8/18

Distribution pattern

Nationwide