Exact FDA event identifier

Event 79693

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

Event summary

Timeline bucket: March 29, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: United Pacific Co Ltd

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

Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02

D-0624-2018

Recall number: D-0624-2018
Initiated: March 29, 2018
Classification: Class II
Status: Terminated
Recalling firm: United Pacific Co Ltd
Quantity: 15,190 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: the product was produced with substandard GMP manufacturing processes.

Code information

Lot #:14122921, Exp.12/30/20119, 15091512, Exp. 9/15/2020, 6032321, Exp. 3/23/2021, 17030921, Exp. 3/09/2022

Distribution pattern

Nationwide within US