Exact FDA event identifier

Event 80840

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

Open FDA event record

Event summary

Timeline bucket: August 15, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Preferred Pharmaceuticals, 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

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

Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9

D-1107-2018

Recall number: D-1107-2018
Initiated: August 15, 2018
Classification: Class II
Status: Terminated
Recalling firm: Preferred Pharmaceuticals, Inc
Quantity: 9 bottles consisting of 90 tables each bottle

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: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Lot # G2017F NDC 68788-6882-9

Distribution pattern

Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.