Exact FDA event identifier

Event 93101

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

Event summary

Timeline bucket: September 20, 2023
Product types: Drug
Classifications: Class I
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

Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.

D-0049-2024

Recall number: D-0049-2024
Initiated: September 20, 2023
Classification: Class I
Status: Terminated
Recalling firm: KVK-Tech, Inc.
Quantity: 1488 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Foreign Tablets

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.

Code information

Lot # 17853A, Exp. 06/30/2027

Distribution pattern

Nationwide in the USA and PR