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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90127

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 02, 2022
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

2 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 2

Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09

D-0886-2022
Recall number
D-0886-2022
Initiated
May 02, 2022
Classification
Class II
Status
Terminated
Recalling firm
RemedyRepack Inc.
Quantity
26/90 count bottles = 2,340 tablets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
AZIDO 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- AZIDO Impurity levels observed to be above acceptable limits.

Code information

Lot # B1329507-082921, exp. date 08/31/2022 B1348363-091421, exp. date 09/30/2022 B1387286-101021, exp. date 10/31/2022 B1390974-101221, exp. date 10/31/2022 B1426010-110521, exp. date 11/30/2022

Distribution pattern

Product was distributed to FL, SC and VA

drug · product 2 of 2

Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09

D-0887-2022
Recall number
D-0887-2022
Initiated
May 02, 2022
Classification
Class II
Status
Terminated
Recalling firm
RemedyRepack Inc.
Quantity
30 bottles/90 count = 2,700 tablets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
AZIDO 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- AZIDO Impurity levels observed to be above acceptable limits.

Code information

Lot # B1364261-092721, exp. date 09/30/2022 B1377667-100521, exp. date 10/31/2022 B1412576-102621, exp. date 10/31/2022 B1436925-111321, exp. date 11/30/2022

Distribution pattern

Product was distributed to FL, SC and VA