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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81500

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

Open FDA event record

Event summary

Timeline bucket
November 02, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Golden State Medical Supply 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

IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90.

D-0263-2019
Recall number
D-0263-2019
Initiated
November 02, 2018
Classification
Class II
Status
Terminated
Quantity
2,439 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodiethylamine (NDEA
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: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.

Code information

Lot Numbers: B160003; Exp. 09/19 B160004; Exp. 09/19

Distribution pattern

Product was distributed throughout the United States.

drug · product 2 of 3

IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.

D-0264-2019
Recall number
D-0264-2019
Initiated
November 02, 2018
Classification
Class II
Status
Terminated
Quantity
15,917 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodiethylamine (NDEA
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: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.

Code information

Lot Numbers: 30-count bottles: GS019526; Exp. 11/19 GS020252; Exp. 11/19 GS020958; Exp. 11/19 Lot Numbers: 90-count bottles B161003; Exp. 09/19 B161004; Exp. 09/19 B161006; Exp. 09/19 B161007; Exp. 09/19 B161008; Exp. 11/19 B161009; Exp. 11/19 B161010; Exp. 11/19 C161001; Exp. 02/20 C161003; Exp. 05/20

Distribution pattern

Product was distributed throughout the United States.

drug · product 3 of 3

IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.

D-0265-2019
Recall number
D-0265-2019
Initiated
November 02, 2018
Classification
Class II
Status
Terminated
Quantity
12,502 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-nitrosodiethylamine (NDEA
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: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.

Code information

Lot Numbers: 30-count bottles GS019036; Exp 09/19 GS019073; Exp. 09/19 GS021472; Exp. 11/19 GS021530; Exp. 11/19 GS022234; Exp. 02/20 90-count bottles B162009; Exp. 09/19 B162010; Exp. 09/19 B162011; Exp. 09/19 B162012; Exp. 11/19 B162013; Exp. 11/19 B162014; Exp. 11/19 B162015; Exp. 11/19 C162001; Exp. 02/20

Distribution pattern

Product was distributed throughout the United States.