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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84184

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

Open FDA event record

Event summary

Timeline bucket
November 01, 2019
Product types
Drug
Classifications
Class II
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

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

Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16

D-0532-2020
Recall number
D-0532-2020
Initiated
November 01, 2019
Classification
Class II
Status
Terminated
Recalling firm
KVK-Tech, Inc.
Quantity
1534 bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection

Code information

Lot #: 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN

Distribution pattern

Nationwide within the United States