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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97344

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

Open FDA event record

Event summary

Timeline bucket
July 22, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Taizhou Kangping Medical Science And Technology 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

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

BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01

D-0589-2025
Recall number
D-0589-2025
Initiated
July 22, 2025
Classification
Class II
Status
Ongoing
Quantity
3.85 million Cartons

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility.

Code information

Lot Numbers: 220583459, 230553459, 232743459, 110523, 031524, 052224, 247793459

Distribution pattern

NY

Field note

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