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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82314

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

Open FDA event record

Event summary

Timeline bucket
March 05, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
AVKARE 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

3 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 3

Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15

D-1044-2019
Recall number
D-1044-2019
Initiated
March 05, 2019
Classification
Class II
Status
Terminated
Recalling firm
AVKARE Inc.
Quantity
N/A

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

Lots: 20961 Exp. 09/2019; 20477 Exp. 08/2019

Distribution pattern

Nationwide.

drug · product 2 of 3

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15

D-1045-2019
Recall number
D-1045-2019
Initiated
March 05, 2019
Classification
Class II
Status
Terminated
Recalling firm
AVKARE Inc.
Quantity
N/A

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

Lot: 19454 Exp. 04/30/2019

Distribution pattern

Nationwide.

drug · product 3 of 3

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15

D-1046-2019
Recall number
D-1046-2019
Initiated
March 05, 2019
Classification
Class II
Status
Terminated
Recalling firm
AVKARE Inc.
Quantity
N/A

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

Lot: 19326 Exp. 03/31/2019

Distribution pattern

Nationwide.