Press Release – Jan. 18, 2019
Jan 18, 2019
Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, Nnitrosodiethylamine (NDEA) in the Products.<Read PDF: >
Press Release – Dec. 14, 2018
Dec 14, 2018
FOR IMMEDIATE RELEASE – CRANBURY, NEW JERSEY - December 14, 2018 On July 12, 2018, Prinston Pharmaceutical Inc. announced that one of its affiliated companies, Solco Healthcare, LLC, based in Cranbury, New Jersey, voluntarily recalled all lots of Valsartan Tablets, 40mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5g, 160mg/25mg, 320mg/12.5mg and 320mg/25mg, to the consumer level. This product recall was due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), in a drug ingredient made by the manufacturer, Zhejiang Huahai Pharmaceutical Co. Ltd., in which the ingredient was used in the manufacture of the subject lots. Subsequently, as a result of an FDA inspection of the manufacturer’s Linhai plant in China, the FDA issued certain observations regarding the plant’s operations and processes, and the company responded to those observations in a detailed and lengthy submission to the FDA, which was supplemented after certain validation testing was completed of newly implemented manufacturing and testing processes and procedures. On November 29, 2018, the FDA, having reviewed these submissions, issued a warning letter to the company requesting that further corrective actions be implemented to ensure the investigation of quality-related complaints, and requiring the company to evaluate changes to its manufacturing processes to control the level of impurities in products made at the plant. The company is now in the process of implementing additional changes in its processes and procedures to respond to the FDA’s warning letter, the completion of which are expected soon. Regrettably, there have been reports in the media significantly misinterpreting and mischaracterizing the FDA’s warning letter and disregarding all of the positive, proactive steps which the company has implemented and will continue to implement. For example, a press report characterized the FDA’s warning letter as stating that the impurity found in Valsartan could have been discovered by the company two years prior to the recall. That is not correct. As a result of an inquiry received from a customer this year, the company investigated its Valsartan product to determine the nature of the impurity and devised a special test to isolate and identify it as NDMA. The company thereafter took quick action to notify regulatory agencies and customers, and immediately stopped production, quarantined inventory, and initiated the voluntary recall. Press reports also erroneously identify as Valsartan a customer-returned product identified by the FDA in its warning letter as Levetiracetam, a different product, and criticize the company’s retesting and reprocessing of this product for resale notwithstanding its compliance with product release specifications. Prinston Pharmaceutical, Solco Healthcare, Zhejiang Huahai, and their affiliated companies assure the public, drug prescribers and patients that they are taking every step to ensure that their products remain safe, therapeutically effective, and meet the highest standards. They and their dedicated employees are also cooperating fully with the FDA and regulatory agencies in other countries to address matters relating to the Valsartan recall.<Read PDF: >
Press Release – Update on Valsartan API – A Statement from the Company
Aug 21, 2018
FOR IMMEDIATE RELEASE - CRANBURY, NEW JERSEY, August 21, 2018. Huahai US Inc., a subsidiary of Zhejiang Huahai Pharmaceutical Co. Ltd is issuing a statement. Recent articles in several print and on-line media have misrepresented information about the discovery of a trace amount of a genotoxic impurity in Valsartan, an active pharmaceutical ingredient (API) made by Zhejiang Huahai Pharmaceutical Ltd. (the Company). These articles have incorrectly suggested that the discovery and identification of this impurity occurred one year or more ago. Their authors speculate that FDA inspections of the Company’s manufacturing facilities in 2016 and 2017 disclosed the presence of this impurity, when, in fact, both inspections were ultimately closed by the FDA with its issuance of Establishment Inspection Reports on January 17, 2017 and September 15, 2017, respectively, and without any finding of a genotoxic impurity in the Company’s Valsartan API. In truth, and as described below in correct temporal sequence, the discovery of this impurity in the Company’s API was made by the Company in June 2018 during a review of manufacturing and optimization processes. After further analyses and confirmations, regulatory authorities were notified promptly and recall actions were voluntarily initiated by the Company for the remaining API in the Company’s and its customers’ inventories. In compliance with all product specifications and manufacturing processes approved by domestic and international regulatory agencies, the Company has manufactured and distributed its Valsartan API for many years in conformity with international cGMP requirements. In early June of this year, during a review of its manufacturing processes, the Company discovered an unexpected impurity in its Valsartan API which, after further testing and consultation with toxicology experts, was determined to be N-nitrosodimethylamine (NDMA), which is classified as a carcinogen with very limited evidence of human carcinogenicity. Out of an excess of caution, and contemporaneous with confirmatory technical evaluations, the Company on its own initiative isolated its storage of Valsartan API on hand, suspended its further release and manufacture, and notified the FDA and other regulatory agencies of these findings. Customers were subsequently notified as well and instructed to suspend the further use of the Company’s Valsartan API. The Company’s voluntary recall of its Valsartan API was then initiated, and periodic informational updates have been furnished to both regulatory agencies and customers in press releases and additional communications. To protect human health, recalls at the consumer level are being undertaken by the Company and its affiliates, and these will continue under the close supervision of the FDA and regulatory agencies in all affected countries.
Meet us AT CPhI Madrid
Tuesday, 11th August 2015 12:22
HHUS will be exhibiting at CPhI Madrid, 2015 – come see us at Booth # 9C20.
Join us on DCAT
Monday, 9th March 2015 16:22
We will attend DCAT 2015 from March 16 to March 19 at Waldorf Tower Suite 34A. All customers and friends are welcome to stop by and enjoy our hospitality.
See you on CPhI
Friday,22nd August 2014 4:09pm
We are going to attend CPhI from October 7th to 9th. Please visit us at booth #5L 31
L.t. Governor Kim Guadagno visited Huahai US
Wednesday, 24th July 2014 3:27pm
Zhejiang HuahaiPharmaceutical Co Ltd Signs Strategic Cooperation Agreements
Tuesday, 10 Sep 2013 08:00pm EDT
Zhejiang Huahai Pharmaceutical Co Ltd announced that it has signed a strategic cooperation agreement with Institute of Pharmacology and Toxicology, Academy of Military Medical Sciences, for cooperation partnership on research, development and industrialization of central nervous system drugs. The two parties also signed a cooperation agreement for research and development of antidepressant VL-0919.
Find us in Pharma ChemOutsourcing
We will be joining Pharma ChemOutsourcing in September 13&14, 2013.