Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82532

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

Open FDA event record

Event summary

Timeline bucket
March 14, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
RemedyRepack 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

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 50mg Tablet, 30 count each blister card.

D-1081-2019
Recall number
D-1081-2019
Initiated
March 14, 2019
Classification
Class II
Status
Terminated
Recalling firm
RemedyRepack Inc.
Quantity
33 blister cards of 30 = 990 tablets

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; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).

Code information

70518-0588-01, Lot #: J0328416-101518, Exp. Date: 10/2019

Distribution pattern

Product was distributed to one sole customer, Miami, FL.