Exact FDA event identifier

Event 82335

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

Open FDA event record

Event summary

Timeline bucket: March 06, 2019
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

Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.

D-1051-2019

Recall number: D-1051-2019
Initiated: March 06, 2019
Classification: Class II
Status: Terminated
Recalling firm: Preferred Pharmaceuticals, Inc
Quantity: 530

App-derived interpretation

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

impurity, N-Methylnitrosobutyric acid (NMBA

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: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.

Code information

Count, lots, expiry: a) 30-count bottle C2218C, exp 9/2020, D1318E, exp 10/2020; b) 90-count bottle C2719J, exp 9/2020, E1818B, exp 10/2020.

Distribution pattern

California, Georgia, Indiana