Exact FDA event identifier

Event 69808

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

Event summary

Timeline bucket: July 18, 2014
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Spectrum Laboratory Products

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

Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.

D-0255-2015

Recall number: D-0255-2015
Initiated: July 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Spectrum Laboratory Products
Quantity: 16 Bottles

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; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.

Code information

Lot #: 1BJ0479; Expiry: 06/2017

Distribution pattern

U.S.: California.