Prinston Pharmaceutical Inc
Complete recall history across all FDA and CPSC categories — 16 total recalls
Prinston Pharmaceutical Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (16)
FDA drug safety enforcement actions by Prinston Pharmaceutical Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 18, 2019 | Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... | Class II |
| Jan 18, 2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Onl... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... | Class II |
| Jan 18, 2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... | Class II |
| Jan 18, 2019 | Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huah... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... | Class II |
| Jan 18, 2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... | Class II |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tab... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Ta... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Ta... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
| Jul 13, 2018 | Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
| Jul 13, 2018 | Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
| Jul 13, 2018 | Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only M... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
| Jul 13, 2018 | Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only M... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tabl... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tabl... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
| Nov 29, 2017 | Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Z... | Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker... | Class II |
| May 30, 2016 | Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufa... | Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327... | Class III |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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