Exact FDA event identifier

Event 84827

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

Event summary

Timeline bucket: January 28, 2020
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: B AND A TRADING CORPORATION

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

Kushim Tablets (Gushim) 45-count packages, Label in foreign language

D-0840-2020

Recall number: D-0840-2020
Initiated: January 28, 2020
Classification: Class II
Status: Terminated
Recalling firm: B AND A TRADING CORPORATION
Quantity: 40 packages

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine

Code information

Lot #: H003

Distribution pattern

NY & NJ only