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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86487

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

Open FDA event record

Event summary

Timeline bucket
March 12, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Direct Rx

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

Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90

D-0032-2021
Recall number
D-0032-2021
Initiated
March 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
Direct Rx
Quantity
33 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity detected to be N-Methylnitrosobutyric acid (NMBA
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviation

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.

Code information

Lot: 12DE1806 Exp. 01/31/2021

Distribution pattern

FL