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Prinston Pharmaceutical Inc

FDA Regulatory Profile

Prinston Pharmaceutical Inc has 16 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest recall
D-0410-2019 · Class II · Jan 18, 2019
Latest inspection
Aug 26, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls16Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0410-2019Class IIIrbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by…Jan 18, 2019
D-0409-2019Class IIIrbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co…Jan 18, 2019
D-0412-2019Class IIIrbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai…Jan 18, 2019
D-0413-2019Class IIIrbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by…Jan 18, 2019
D-0411-2019Class IIIrbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai…Jan 18, 2019
D-0973-2018Class IISolco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count…Jul 13, 2018
D-0974-2018Class IISolco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle…Jul 13, 2018
D-0972-2018Class IISolco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles…Jul 13, 2018
D-0971-2018Class IISolco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by…Jul 13, 2018
D-0969-2018Class IISolco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by…Jul 13, 2018
D-0970-2018Class IISolco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by…Jul 13, 2018
D-0976-2018Class IISolco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles…Jul 13, 2018
D-0968-2018Class IISolco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by…Jul 13, 2018
D-0975-2018Class IISolco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle…Jul 13, 2018
D-0209-2018Class IIValsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai…Nov 29, 2017
D-1049-2016Class IIIIrbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang…May 30, 2016

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 26, 2025Somerset, NJDrugsNo Action Indicated (NAI)3009298353
Apr 5, 2016Somerset, NJDrugsNo Action Indicated (NAI)3009298353
Nov 30, 2012Somerset, NJDrugsNo Action Indicated (NAI)3009298353

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3009298353Somerset, NJ3Aug 26, 2025

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.