Search Results for Recall

Showing 1 – 25  of 49

FDA Warns of Bacterial Contamination in PharmaTech Liquid Drugs By Michael Mezher - Published 09 August 2017

The US Food and Drug Administration (FDA) on Wednesday warned patients and health care professionals not to use liquid drugs made by Florida-based contract manufacturing organization (CMO) PharmaTech LLC due to possible bacterial contamination.

Categories: News, US, FDA, Drugs, Labeling, Manufacturing

Tags: PharmaTech, Burkholderia cepacia, B. cepacia, Recall

House Bill Seeks to Add Mandatory Drug Recall Authority to FDA’s Arsenal By Zachary Brennan - Published 16 February 2017

Rep. Rosa DeLauro (D-CT) on Thursday introduced a new bill that will allow the US Food and Drug Administration (FDA) to do what many assume it already can: Require pharmaceutical or over-the-counter drug companies to stop marketing unsafe products.

Categories: US, FDA, Drugs, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: DeLauro, mandatory drug recall, FDA authority, drug recalls, homeopathic

CDRH Speeds Release of Device Recall Information By Zachary Brennan - Published 03 January 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday began posting medical device recall information in a searchable database much earlier than the agency ever has before.

Categories: News, US, CDRH, Compliance, Crisis management, Government affairs, Medical Devices, Postmarket surveillance

Tags: device recalls, FDA recalls, recall coordinators

FDA: Custom Ultrasonics' Endoscope Reprocessors Still Unsafe By Michael Mezher - Published 17 August 2016

The US Food and Drug Administration (FDA) on Wednesday said it is maintaining its recommendation against the use of Custom Ultrasonics' System 83 Plus automated endoscope reprocessors (AERs) to clean duodenoscopes after finding the reprocessors were not adequately validated last November.

Categories: News, US, FDA, Crisis management, Medical Devices, Postmarket surveillance

Tags: Endoscope, Duodenoscopes, Custom Ultrasonics', Superbug Outbreak, CRE, Recall

Florida CMO Recalls All Lots of Liquid Drugs Due to Bacteria Outbreak By Michael Mezher - Published 10 August 2016

Contract manufacturing organization PharmaTech on Monday announced a voluntary recall of all of its liquid drug formulations made at its Davie, Florida facility over a 10-month period after being linked to a multi-state Burkholderia cepacia outbreak.

Categories: News, US, FDA, Drugs, Medical writing, Product withdrawl and retirement, Quality

Tags: Contract manufacturing organization, PharmaTech, Burkholderia cepacia, B. cepacia, Docusate sodium, Recall

Medical Device Recalls Plunge to Near-Record Lows in First Quarter of 2015 By Alexander Gaffney, RAC - Published 06 April 2015

The number of medical device recalls appears to have plunged during the first quarter of 2015, a review of the US Food and Drug Administration's (FDA) data by Regulatory Focus has revealed.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance, Product withdrawl and retirement

Tags: Medical Device Recalls, openFDA, Recall Classification

Recall or Removal? New FDA Device Guidance Clarifies Murky Definitions By Alexander Gaffney, RAC - Published 14 October 2014

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has finally put the finishing touches on a controversial guidance regarding how to distinguish the recall of a device from a market withdrawal.

Categories: News, US, CDRH, Distribution, Medical Devices, Postmarket surveillance

Tags: Recall, 21 CFR 806, Guidance, Final Guidance, Correction, Removal, Enhancement

Massive Recall of Medical Devices Largest Ever Recorded by FDA By Alexander Gaffney, RAC - Published 02 September 2014

A massive medical device recall reported last week by the US Food and Drug Administration (FDA) is the largest-ever single-day event on record, according to data recently made available by FDA.

Categories: News, US, CDRH, Medical Devices, Packaging, Product withdrawl and retirement

Tags: Recall, Medical Device Recall, Sterility, Packaging, Class I Recall

Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns By Alexander Gaffney, RAC - Published 11 August 2014

Recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the US Food and Drug Administration (FDA) late last month.

Categories: News, US, CDER, Drugs, Postmarket surveillance, Product withdrawl and retirement

Tags: Recall, Drug Recalls, FDA Recalls, Drug Recalls Increasing, Class I Recall, Class II Recall, Class II Recall

As Medical Marijuana Hits Mainstream, Regulators Take Notice With Safety Recalls By Alexander Gaffney, RAC - Published 12 May 2014

Categories: Canada, Health Canada

Tags: Medical Marijuana, Contamination, Recall, Latest News

UDI Implementation Still on the Horizon, FDA Updates List of Devices Which Must Be Tracked By Alexander Gaffney, RAC - Published 28 March 2014

Categories: US, FDA

Tags: 21 CFR 821, Tracking, Recall, Latest News, medical device

FDA Moves Ahead With Plan to Make Device Recall and Removal Reporting More Efficient By Alexander Gaffney, RAC - Published 28 March 2014

Categories: US, FDA

Tags: eSubmitter, 21 CFR 806, 806, ESG, Recall, Latest News, medical device

Brazil Launches New Adverse Event Reporting System By Louise Zornoza, RegLink - Published 31 January 2014

Categories: Regulatory Update, Anvisa

Tags: ADR, AER, Reporting, Adverse Event, Recall, brazil

FDA Unveils Strengthened Medical Device Reporting Database With New Features By Alexander Gaffney, RF News Editor - Published 16 December 2013

Categories: US, FDA, CDRH

Tags: Recall, 510(k), PMA, medical device

Device Recalls Surge While Pharma Offers Mixed News in Latest Recall Report By Alexander Gaffney, RF News Editor - Published 12 November 2013

Categories: US, FDA

Tags: Stericycle, ExpertRECALL, Recall, Latest News, pharmaceutical, recalls, drug, medical device

USPlabs Succumbs to Regulatory Pressure, Recalls Supplement Linked to Hepatitis Outbreak By Alexander Gaffney, RF News Editor - Published 12 November 2013

Categories: US, FDA

Tags: Recall

Organic Particulates Lead to Recall for B.Braun Antibiotic By Alexander Gaffney, RF News Editor - Published 16 October 2013

Categories: US, FDA

Tags: Recall

Recalls by Hospira Continue to Mount as Company Finds Hair, Glass, Steel and Brass By Alexander Gaffney, RF News Editor - Published 03 October 2013

Categories: US

Tags: Hospira, Recall

Breaking Device: Too-High Device at Risk of Breakdown, Says Company By Alexander Gaffney, RF News Editor - Published 30 September 2013

Categories: US, FDA

Tags: Recall, medical device

FDA Announces Bevy of Sterility-Related Recalls By Alexander Gaffney, RF News Editor - Published 09 September 2013

Categories: US, FDA

Tags: Sterility, McNeil, J&J, Recall

Fallout from Deficient Contract Testing Facility Continues, Prompting Fourth Company to Issue Recall By Alexander Gaffney, RF News Editor - Published 06 September 2013

Categories: US, FDA

Tags: Pharmaceutical Compounding, Recall

Human Hair Found in IV Solution Prompts Hospira Recall By Alexander Gaffney, RF News Editor - Published 03 September 2013

Categories: US, FDA

Tags: Hospira, Recall

What Can You Say?: Uncovering Trends in Recent Medical Device Enforcement Actions By Allyson B. Mullen and Anne K. Walsh - Published 02 September 2013

Due to multi-million-dollar (and sometimes billion-dollar) settlements, the vast majority of headlines regarding off-label promotion cases in recent years have involved drugs. Although less prominent, the US Food and Drug Administration (FDA) has steadily continued to act against medical device manufacturers for the same conduct, mostly in the form of Warning Letters. This article analyzes these Warning Letters to provide insight into FDA's current and emerging areas of interest and impart important lessons for the device industry to avoid future enforcement related to its promotional practices.

Categories: Features, US, FDA

Tags: Recall, warning letters, enforcement, medical device

Watchdog Group: FDA Failed to Shut Down Compounder Earlier, at Blame for Outbreak of Infections By Alexander Gaffney, RF News Editor - Published 14 August 2013

Categories: US, FDA

Tags: Infections, Compounding Pharmacy, Compounding, Sterility, Sterile, Public Citizen, Recall, Latest News

Compounded Products Linked with Potential Deadly Infections, Putting New Pressure on FDA, Congress By Alexander Gaffney, RF News Editor - Published 12 August 2013

Categories: US, FDA

Tags: Infections, Compounding Pharmacy, Compounding, Sterility, Sterile, Recall, Latest News