Category: Rx-360 Alerts

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan…
Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due [...]
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FDA Warns CanaRx for Selling Unapproved, Misbranded and Unsafe Imported Drugs to Unsuspecting Americans
The U.S. Food and Drug Administration posted a warning letter to CanaRx for facilitating the distribution of unapproved new drugs and [...]
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Memorandum on Combating Trafficking in Counterfeit and Pirated Goods
Issued on: April 3, 2019 President Donald J. Trump issued a memorandum on Combating Trafficking in Counterfeit and Pirated Goods. [...]
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Fraudulent Correspondence – Warning to all Members & Non-Members
Dear Rx-360 Members & Non-Members, Rx-360 has been made aware that fraudulent correspondence was sent to a small number of [...]
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FDA Says Up to Two Million People Exposed to Likely Carcinogens in Blood-Pressure Drugs
As many as two million people world-wide have been exposed to a class of generic blood-pressure drugs containing probable human [...]
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Revisoin 7 of ICH Q3C Guideline for Residual Solvents
In October 2018, the ICH Management committee issued Revisoin 7 of ICH Q3C Guideline for Residual Solvents.  The only change [...]
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Five additional countries to benefit from EU-US mutual recognition agreement for inspections | European Medicines…
The US FDA has completed the capability assessment for an additional 5 EU regulators in November 2018: Estonia (State Agency [...]
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Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP
Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 [...]
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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality…
Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. Overseeing the quality and [...]
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FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications
The U.S. Food and Drug Administration today released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou [...]
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Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to [...]
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Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable…
The FDA remains committed to ensuring that FDA-approved drugs are safe and effective for Americans. As part of this commitment, [...]
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Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide
Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product [...]
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5 Strategies To Combat Counterfeit Drugs And Other Pharma Supply Chain Threats
It’s hard enough to detect errors in the entire process of manufacturing and distributing one’s own pharmaceutical products, but pharma [...]
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Mylan and Pfizer Report New Issues Affecting Some EpiPens That Can Delay Treatment
More than a month after Mylan and Pfizer reported to Health Canada that there are new issues affecting some EpiPens, [...]
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FDA Gains New Powers to Block Illicit Drug Imports
A new US law that aims to tackle the national opioid crisis has been welcomed by FDA Commissioner Scott Gottlieb, [...]
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FDA Updates on Valsartan Recalls
FDA releases method for detection and quantification of both NDMA and NDEA Update [10/11/2018] ] FDA is posting a redeveloped combined [...]
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The Uphill Fight Against Fake Prescription Drugs
Tosh Ackerman took part of what he thought was a Xanax pill to help him sleep one night three years [...]
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MHRA Says Falsified Medicines Directive Could Cost £500m Over Ten Years
The Medicines and Healthcare products Regulatory Agency (MHRA) has estimated that implementing the Falsified Medicines Directive (FMD) in the UK [...]
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Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble…
Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 [...]
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Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center…
Millions of Americans take medication daily to control their blood pressure. We recently found that some generic versions of one [...]
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FDA Announces Voluntary Recall of Montelukast Tablets by Camber Pharmaceuticals Due to Incorrect Drug in…
The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot [...]
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Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida…
Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal [...]
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URI Chemistry Professor Develops New Contaminant Detection Technique for Blood Thinner Heparin
In 2008, a contaminant eluded the quality safeguards in the pharmaceutical industry and infiltrated a large portion of the supply [...]
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Over Half Of U.S. States Have Now Seen Fatalities From Counterfeit Drugs Made With Fentanyl
During a roundtable discussion focused on the nation’s worsening opioid crisis, advocates for ensuring a safe drug supply shared new [...]
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FDA Alerts Drug Makers of a Recall of Porcine Thyroid API from Sichuan Friendly Pharmaceutical…
FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, [...]
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Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets
Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of [...]
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Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due…
Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 [...]
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Chinese Vaccine Maker Made 500,000 Substandard Baby Vaccines: Xinhua
A Chinese drug company produced nearly 500,000 substandard vaccines for babies, roughly double an earlier estimate by authorities investigating a [...]
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Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets
As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg [...]
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Proposed Changes To WHOIS System Privacy Will Help Hide Internet Criminals, NABP Director Warns
Every week brings new details of the negative externalities of social media and e-commerce websites. But fake bots aren’t the [...]
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EMA Reviewing Medicines Containing Valsartan from Zhejiang Huahai Following Detection of an Impurity
The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a company [...]
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EU Sees One in 5,000 Cancer Risk from Tainted China Heart Drug
The European Medicines Agency estimates there could be one extra case of cancer for every 5,000 patients taking a common [...]
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China Heart Drug Sold Globally May Have Had Impurity Since 2012
The revelation that the problem likely dates back to changes in manufacturing processes at Zhejiang Huahai Pharmaceutical six years ago [...]
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FDA Updates on Valsartan Recalls
Update [8/2/2018] FDA continues to evaluate valsartan-containing products and has updated the list of products included in the recall and the list of products not included [...]
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Could Blockchain Solve China’s Food and Drug Safety Problems?
A scandal involving a Chinese pharmaceutical firm that forged documents relating to a rabies vaccine for babies has sparked a [...]
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RECALL: Blood Pressure Medication, Valsartan, Recalled Due to Possible Contaminants
The Food and Drug Administration has announced a voluntary recall of a widely prescribed blood pressure medication made in China, reviving fears [...]
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Outrage in China’s Latest Scandal: Unsafe Vaccines
A scandal over faulty vaccines in China has sparked anger on social media, underscoring the difficulties regulators face in rebuilding [...]
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Rx-360 Supply Chain Security Steering Committee Publishes White Paper
The Supply Chain Security Steering Committee is please to announce the release of the white paper “Taking a Collaborative Approach [...]
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FDA Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food,…
09May2018 FDA issued the draft guidance Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, [...]
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Semi Truck, Nearly $1 million in Cancer Drugs Stolen at Tennessee Truck Stop
The Giles County Sheriff’s Office reports nearly $1 million of cancer drugs were stolen with a semi truck on Thursday. [...]
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Rx-360 Supplier Led Working Group Releases All Modules of Supplier Assessment Questionnaire Version 2.0
The Rx-360 Supplier Led Working Group (SLWG) is very pleased to announce the release of version 2.0 of the Rx-360 [...]
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Rx-360 Supplier Led Working Group Releases Best Practices for Quality Agreements Version 2.0.
The Supplier Led Working Group is pleased to announce the release of Best Practices for Quality Agreements Version 2.0. Quality [...]
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FDA Orders Recall of Salmonella-Tainted Kratom Products Nationwide
Various brands of kratom supplements have been linked to nearly 90 cases of salmonella across 35 states. Click Here to [...]
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Rx-360’s New Data Integrity Library Resource
About the Data Integrity Library: This library is a collection of up to date publications associated with the topic of data [...]
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FDA Office of Pharmaceutical Quality Issues Their Annual Report
On February 28, 2018, FDA’s Office of Pharmaceutical Quality published their first public annual report describing their 2017 accomplishments.  The [...]
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WHO Issues Report on Global Surveillance and Monitoring System for Substandard and Falsified Medical Products
On February 14, 2018, the World Health Organization (WHO) issued a report summarizing data gathered by the WHO Global Surveillance [...]
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Rx-360 Supplier Led Working Group Releases Version 2.0 of Product Information Module (Module 3)
The Rx-360 Supplier Led Working Group (SLWG) is very pleased to announce the release of version 2.0 of the Rx-360 [...]
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Work plan for the joint CHMP/CVMP Quality Working Party (QMP) for 2018
On December 4, 2017, the CHMP/CVMP Working Party issued their final work plan for the joint Quality Working Party (QWP) [...]
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Work Plan for the Biologics Working Party (BWP) for 2018
On December 14, 2017, the EMA published its adopted Work Plan for the Biologics Working Party 2018. The Plan outlines [...]
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Amidst Fraud Concerns in China, E&C Leaders Ask FDA for Contingency Plan for U.S. Heparin…
FOR IMMEDIATE RELEASE February 2, 2018 Contact: Press Office (202) 226-4972 Amidst Fraud Concerns in China, E&C Leaders Ask FDA [...]
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Could Blockchain Technology Be Used For DSCSA Compliance?
If your email inbox is anything like mine it has recently been swamped with articles and webinar notices about the [...]
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CDER Issues Planned Guidance Agenda for CY2018
On January 19, 2018, CDER issued their updated CY2018 Guidance Agenda, which outlines new and revised draft guidances CDER plans [...]
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U.S. FDA Issues Draft Guidance on CMC Changes to an Approved Application for Certain Biologics
On December 22, 2017, FDA issued a draft guidance to assist applicants and manufacturers of certain licensed biological products in [...]
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U.S. FDA Announces Pilot Program – Fostering Medical Innovation: Case for Quality Voluntary Medical Device…
On December 28, 2018, FDA announced its Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ [...]
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U.S. Announced Proposed Program – Voluntary Malfunction Summary Reporting Program for Manufacturers
On December 26, 2017, FDA issued a Federal Register Notice announcing a proposed program permitting medical device manufacturers to submit malfunction medical [...]
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U.S. Announced Proposed Program – Voluntary Malfunction Summary Reporting Program for Manufacturers
On December 26, 2017, FDA issued a Federal Register Notice announcing a proposed program permitting medical device manufacturers to submit malfunction medical [...]
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U.S. FDA Issues Draft Guidance on The Least Burdensome Provisions: Concepts and Principles
On December 15, 2017, FDA issued a new, draft guidance that describes how FDA intends to implement provisions enacted by [...]
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FDA Provides Notice to Public of Website Location of CDRH FY 2018 Proposed Guidance Development
On December 12, 2017, FDA issued a Federal Register Notice announcing the website location where the Agency will post two lists of [...]
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U.S. FDA Issues Revised MAPP on Naming of Drug Products Containing Salt Drug Substances
The Manual of Policies and Procedures (MAPP) (effective December 7, 2017) describes how the Center for Drug Evaluation and Research [...]
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Press Release from First Ever Fight the Fakes Face to Face Partner Meeting
PRESS RELEASE Global coalition in the fight against falsified medicines meets in Brussels as it welcomes its 35th partner Monday [...]
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FDA Issues Draft Guidance on ANDA Submissions – Amendments to Abbreviated New Drug Applications under…
On October 3, 2017, FDA issued draft guidance to explain to applicants how the review goals established as part of [...]
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FDA Issues Draft Guidance on Refuse-to-Receive Standards: Questions and Answers
On October 3, 2017, FDA issued draft guidance to assist applicants preparing to submit to FDA abbreviated new drug applications [...]
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Rx-360 Supplier Led Working Group Publishes Whitepaper
The Supplier Led working group is pleased to announce the release of the final version of the Rx-360 Quality Elements [...]
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Pharmaceutical Supply Chain Security Risk Assessment for Shipping Lanes
Abbvie Eli Lilly and Company Sensitech Inc TEVA Pharmaceutical Industries Ltd. MSD McKesson Canada GSK Purdue Pharma Technologies Inc Roche [...]
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Request for Information – Disaster Impact Assessment in Puerto Rico and Other Locations
As you most of the recipients of this information are aware, Puerto Rico and many other locations in the Caribbean [...]
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Hurricane Maria´s Impacts on Infrastructure and Life Sciences and Healthcare Supply Chains in Puerto Rico
Following the passing of Hurricane Maria on September 20, Puerto Rican news sources have been reporting on widespread damage to [...]
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The Plight of BioPharma Supplies at Missionary Hospitals in Africa
Faith-based organizations (FBOs) provide a substantial portion of the health care services in many African countries. FBO facilities do consider [...]
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Hurricane Maria Threatens to Disrupt Pharma Supply Chain Activity in Puerto Rico and Other Caribbean…
This alert has been provided by BSI. September 20, 2017 The recent movement of Hurricane Maria over Puerto Rico and [...]
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African Medicines Agency endorsed by Ministers of Health
In a collective effort to curb and prevent the circulation of counterfeit drugs in Africa, the Ministers of Health aim [...]
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Rx-360 Supplier Led Working Group Releases Version 2.0 of Supplier Assessment Questionnaire
The Rx-360 Supplier Led Working Group (SLWG) is very pleased to announce the release of version 2.0 of the Rx-360 [...]
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FDA Announces Pilot Project Program Under the Supply Chain Security Act
On July 20, 2017, FDA announced its intent to establish a pilot project program under the Drug Supply Chain Security [...]
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Imperial Logistics Supply Chain Academy – Upcoming Educational Programs
Imperial Logistics Supply Chain Academy’s Receiving Management Program and Inventory Management Program will take place from the 14th – 18th of August 2017 [...]
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Raising Awareness with Fight the Fakes
On July 28th, Fight the Fakes raises awareness around World Hepatitis Day.  According to WHO 2015 World Hepatitis report, 325 million people worldwide [...]
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FDA Announces Exemptions from Premarket Notification for Class II Devices
On July 11, 2017, FDA announced a list of class II devices that the Agency has determined based on established [...]
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CBER Publishes their Updated 2017 Guidance Agenda
CBER recently published their updated Guidance Agenda for 2017.  The following documents have been added to this updated Guidance Agenda: [...]
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Serialization will be good for business, pharma says
22-May-2017 More than 70 per cent of drugmakers believe serialization requirements in the US will positively transform their business processes, [...]
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Industry News Headlines
WHA Bans IP Reference In Substandard And Falsified Medicines Intellectual Property Watch … term “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” (SSFFC medical products) with “substandard [...]
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Industry News Headlines
Nano Pharmaceutical Market Research, Key Players, Industry Overview, Supply and Consumption … DailyNewsKs Nano Pharmaceutical Market is expected to witness growth of international market with respect [...]
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New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017
FDA has updated the list of guidance documents intended for publication by CDER in 2017.  The only change from the [...]
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CMDh Q&As – QP declaration
The European Co-ordination group for Mutual Recognition and Decentralised Procedures has recently published a set of Q&As related to QP [...]
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Falsified Medicines in Europe: Enhanced Analytical Capacity for National Laboratories Through the OMCL Network
The European network of Official Medicines Control Laboratories has highlighted how new analytical techniques will support national authorities, such as [...]
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EMA: Quality of Medicines Questions and Answers: Part 1
EMA has recently published additional questions and answers related to whether or not variations are required for removal of the [...]
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Working Group Adds New Resources to Data Integrity Library
The Data Integrity Working Group has added four additional resources (links below) to the Data Integrity Library. We welcome you [...]
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Second Chinese company found shipping APIs from a banned manufacturer
If the FDA has serious concerns about the APIs or drugs made at a facility outside the U.S., it often will [...]
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Monitoring and Reporting Working Group Posts New Resources
The Monitoring and Reporting Group has just launched three more resources to the resource library. We invite you to share these [...]
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Industry News Headlines
Counterfeit drugs are putting the whole world at risk Popular Science A blister pack of faked Artesunate, a drug used to treat malaria, [...]
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Industry News Headlines
EU and US Pledge to Recognize Each Other’s GMP Inspections By Randi Hernandez In a landmark decision, the United States FDA [...]
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Longshore Union Calls for East Coast Port Shutdown
By Marex  2017-02-23 14:01:00 The International Longshoremen’s Association (ILA) is calling for a shutdown at ports along the eastern seaboard and Gulf [...]
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Pharmaceutical Annual Cargo Theft Report
Report provided by the Transported Asset Protection Association TAPA Americas collects, records, analyzes and reports on cargo theft data for [...]
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Falsified packs of cancer drug Votrient found in Germany
Securing Industry 18FEB2017 – Axicorp GmbH has discovered another falsified medicine in the legitimate supply chain in Germany, this time [...]
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Industry News Headlines
Drug-peddling brothers from Lithuania ran international counterfeit medicine scam from Oxford … Oxford Mail Enforcement officers raided the house and storage [...]
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Securing Medical Product Quality Through the Supply Chain
We are very pleased to inform you that the USP is announcing the availability of a CoE Pilot Program on [...]
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An Analysis of FDA FY2016 Drug GMP Warning Letters
Barb Unger, of Unger Consulting Inc., has written a superb article that makes sense of all the complicated and obscure [...]
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FDA Final Repackaging Guidance
FDA has recently issued a final guidance for industry entitled “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing [...]
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96% of Websites Selling Prescription Drugs Found to Be Operating Illegally
As of December 31, 2016, the National Association of Boards of Pharmacy has reviewed over 11,000 websites selling prescription medicine [...]
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FDA says investigations underway into counterfeit medications
ALBANY, GA (WALB) -Justice Department officials say they are concerned that more Americans are buying medication illegally from foreign pharmacies, and [...]
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Strict vetting can help fight counterfeit drugs
The World Health Organization (WHO) estimates that about 10 per cent of global pharmaceutical supply is counterfeit and substandard. The [...]
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MHRA Publishes 2015 GMP Inspection Deficiency Data
On January 11, 2017, MHRA published the 2015 GMP inspection deficiency data trend. The top 10 most cited deficiency groups [...]
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