Exact FDA event identifier

Event 83796

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

Event summary

Timeline bucket: September 12, 2019
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

Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06

D-0141-2020

Recall number: D-0141-2020
Initiated: September 12, 2019
Classification: Class II
Status: Terminated
Recalling firm: Spectrum Laboratory Products
Quantity: 29.1 grams

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: Received notice from supplier that there is potential glass contamination.

Code information

Lot # 1HE0899, 1IB0005, Exp 02/28/2023

Distribution pattern

Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.