Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81395

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

Open FDA event record

Event summary

Timeline bucket
August 24, 2018
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

Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00

D-0093-2019
Recall number
D-0093-2019
Initiated
August 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
RemedyRepack Inc.
Quantity
2 bottles of 90 tablets (180 tablets)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA, a possible impurity
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 NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.

Code information

Lot # B0438903-052118 70518-1220-00

Distribution pattern

Product was distributed to a medical facility in South Carolina