Medical Safety News

02/02/2021

Unipharma, the company heavily promoted by an explant "concierge" to women with BII, has filed for Chapter 11 bankruptcy after years of battles with the FDA over contaminated medicines, including the product Glutadose which was distributed across the US to explant patients and turned out to be contaminated by very serious bacteria. Many women reported getting very ill after being given Glutadose for detox for sick BII ladies.

21/08/2020

BII Uncensored

https://www.facebook.com/permalink.php?story_fbid=184674409706904&id=108961703944842&__xts__[0]=68.ARDzCRnyuNn5Zz-ogr_cP_eBi26Otx2LcX1Sx2SU9QD8LqwDlHf2aRt6TebppRZc6KgMsZR9dpluUZfBbErbiixIwS3UB3k4N7zSRXAY3Il_S6iOop-OHO4JtJ0jUb8x0iEhVHkYjAU9ypvsZ-N-HUQfzWFwkwEj2cXOMhmccvBMUiwEccHBTWy__jwehY3Z5pEvjxdvBxrfsesv7tn_aOB33h4iXEQx-wKvkG9SrD-un-QYtUTSMSpeM--NKZ2pP-wds85Vc0kF3N65grXvD71_9rNWuuxOnVW_W-https://scontent-dfw5-2.xx.fbcdn.net/v/t1.0-9/80346428_111112533729759_541994266818248704_n.jpg?_nc_cat=107&_nc_sid=09cbfe&_nc_ohc=o3n0Z4Hvzw4AX8Xw_pJ&_nc_ht=scontent-dfw5-2.xx&oh=9c7f54ed4bc8180d218a312a348d23b6&oe=5F653D51

21/07/2020

Dr. Feng's full study on BII, just released:

https://journals.lww.com/annalsplasticsurgery/Fulltext/2020/07001/Understanding_Breast_Implant_Illness,_Before_and.19.aspx

luating changes in specific symptoms over time. The purpose of this study was to gain an understanding of symptoms associated with BII, and to evaluate how these symptoms change after removal of breast implants and total capsulectomy (explantation). We hypothesized that patients presenting with BII....

28/12/2019

This is still going on. Be careful with grain-free dog foods.

https://www.fda.gov/animal-veterinary/news-events/fda-investigation-potential-link-between-certain-diets-and-canine-dilated-cardiomyopathy

Latest update on the FDA’s investigation into reports of dilated cardiomyopathy (DCM) in dogs eating certain pet foods.

26/12/2019

https://www.cnn.com/2019/12/26/health/woman-injured-mercury-skin-cream-trnd/index.html

The woman relies on a feeding tube and cannot speak or care for herself. She'd used the toxic cream twice daily for seven years, and her condition worsened after she stopped using it.

26/12/2019

--- PLEASE SHARE ---

Another recent FDA Warning Letter has been submitted to us concerning Unipharma, LLC, the maker of the recalled GLUTADOSE. On 11/06/2019, the FDA noted: "The pretreatment portion also had too numerous to count (TNTC) levels of microorganisms on multiple occasions."

This is very important information because the plant was found dirty and full of Burkholderia cepacia in the central water supply from which all medications were made. Unipharma made CVS Children's cough and cold products in the same vials it packed the Glutadose in and the children's medications had been contaminated and a total of six products by Unipharma recalled. Glutadose was the seventh recall and handled separately because it is a dietary supplement which is handled by cGMP practices instead of being considered a pharmaceutical. This means that it is largely exempt from inspections but because the entire water supply of the manufacturing plant was contaminated with Burkholderia cepacia (a former Pseudomonas strain), the Glutadose which was made with the same unsanitary water was also recalled.

The Unipharma plant had been found dirty from late 2018 until Nov. 2019 and FDA considered this information to be current as of 12/17/2019. This means that potentially ANY AND ALL Glutadose on the market ever made is potentially contaminated because the plant is still not cleaned up as of 12/17/2019.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/unipharma-llc-585388-11062019

20/12/2019

Leviteracetam oral medicine recalled due to bacteria in the liquid.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lannett-issues-voluntary-nationwide-recall-levetiracetam-oral-solution-100mgml-due-microbial?utm_campaign=Lannett%20Issues%20Voluntary%20Nationwide%20Recall%20of%20Levetiracetam%20Oral%20Solution%2C%20100mg%2FMl&utm_medium=email&utm_source=Eloqua

Lannett Company, Inc. today announced that it is voluntarily recalling two (2) lots of Levetiracetam Oral Solution, 100mg/mL to the consumer level due to contamination with Bacillus subtilis. The Bacillus subtilis was identified during an evaluation of a raw material used to manufacture the product

18/12/2019

Bull and Rhino male enhancement product is on recall due to being laced with illegal ingredients. Beware of male sexual enhancement "natural products". Most of them are illegally spiked with uncontrolled amounts of Vi**ra, Cialis, etc.

http://s2027422842.t.en25.com/e/es?s=2027422842&e=285897&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=8a7d7d832c3a4a44842b943c27d01c42&elqaid=10671&elqat=1

18/12/2019

The same Barry's Herb and Vitamin Shop where the fake doctors Arrieta and Barry Nevins were arrested also sold male enhancement drugs named Virility Max with illegal pharma ingredients and was forced to recall them by FDA around the same time some of their employees were arrested for impersonating doctors. Employees of the shop were Barry Nevins, Jeff Rose, Edgar Arrieta.

https://www.sun-sentinel.com/health/fl-xpm-2011-11-14-fl-hk-virility-max-recall-20111114-story.html

https://www.ksdk.com/article/news/makers-of-tainted-supplements-have-criminal-pasts/63-308556770?fbclid=IwAR3VKyFn_6QiFLFxW-0kNIyyeMwGLuTDq7TpJkqdQQ6h7034QH7e-zwNPR4

16/12/2019

https://www.fda.gov/news-events/press-announcements/fda-statement-deputy-commissioner-food-policy-and-response-frank-yiannas-new-steps-protect-consumers

FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements

16/12/2019

https://www.fda.gov/food/dietary-supplements/how-report-problem-dietary-supplements

How to report a serious reaction or illness associated with a dietary supplement.

16/12/2019

https://www.fda.gov/food/dietary-supplements/whats-new-dietary-supplements

Actions on dietary supplements to protect public health

13/12/2019

FDA appoints new chief.

https://www.nytimes.com/2019/12/12/health/fda-stephen-hahn.html

The Food and Drug Administration has been without a permanent commissioner since April, when Dr. Scott Gottlieb resigned.

12/12/2019

***BREAKING NEWS ON GLUTADOSE ***

"Dr.Glutadose" fraudulent scientist "Dr." Edgar Arrieta" was arrested in the past for playing doctor while marketing dietary supplements, was recently again introduced via FB Live as "Dr. Edgar Arrieta, the scientist who developed glutadose".

Beware of false claims on social media! This one was entirely false and fraudulent, as it turned out. Arrieta is NOT a doctor of any kind despite being sold by his co-conspirators online as "Dr. Arrieta" in 2019 again. Please check your Glutadose supply against FDA recall list.

https://www.sun-sentinel.com/news/florida/sfl-vitamin-shop-20111016-story.html?fbclid=IwAR2oaumA3i1uAozuLDBvkhFBPuxxWcSj3MeIws06-0zsh82XGo_MmhmOq_A

08/12/2019

https://www.medscape.com/viewarticle/922248?src=soc_fb_191207_mscpedt_news_mdscp_metformin&faf=1&fbclid=IwAR086h93BMXHWZ9YeYeRuZQeZyZqIhMEn336YHZNKXsFjhmWTO0OgA4WAfQ

The Food and Drug Administration has begun testing samples of metformin for NDMA. The fourth most-prescribed drug in the US, metformin is generally the first medication prescribed for type 2 diabetes.

03/12/2019

Tainted Products Marketed as Dietary Supplements

https://www.fda.gov/media/109066/download

03/12/2019

https://www.consumerreports.org/bottled-water/the-fda-knew-the-bottled-water-was-contaminated-the-public-didnt/

Bottled water contaminated beyond federal limits wasn't recalled from stores, even though the FDA knew about it, a Consumer Reports investigation found.

03/12/2019

From last month, but these are the most recent class I (most serious) FDA recalls. After a recall is initiated, the FDA classifies it according to severity. Class I is most serious, class II is still moderate risk with class III being the lightest. Below are the classifications for last month's most serious recalls, from contaminated medication lots to medical devices.
https://www.fiercebiotech.com/medtech/fda-ranks-separate-recalls-from-abbott-philips-as-class-i

The FDA recently labeled two device recalls as Class I, the most serious, after they were launched by Philips and Abbott earlier this year—including the latter’s CentriMag cardiac support system for open-heart surgeries following the death of a patient. Meanwhile, Philips Medical Systems (Clevel...

28/11/2019

Recalled Glutadose distributed on FB under this post on July 14, 2019. Note the recalled lot #90013.

28/11/2019

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2494591/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6165602/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4626593/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3596321/

28/11/2019

****** FDA advisory on the risk of Burkholderia cepacia in liquid solutions below. ******

" The FDA advises drug manufacturers of non-sterile, water-based drug products that there have been recent product recalls due to Burkholderia cepacia complex (BCC or B. cepacia) contamination.(1, 2, 3) BCC and other water-borne opportunistic pathogens are among the contaminants that can be found in pharmaceutical water systems.

BCC can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents.(4, 5) Detecting BCC bacteria is also a challenge and requires validated testing methods that take into consideration the unique characteristics of different BCC strains.

People exposed to BCC are at an increased risk for illness or infection, especially patients with compromised immune systems.(3, 6)"

https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-drug-manufacturers-burkholderia-cepacia-complex-poses-contamination-risk-non-sterile

This page covers the topics of b. cepacia, BCC, burkholderia cepacia complex in drug manufaturing.

27/11/2019

Chickenpox reactivates meningitis in this patient.

https://www.cnn.com/2019/11/27/health/chickenpox-vaccine-meningitis-study/index.html

Doctors described what they believe are the first known cases of meningitis due to reactivation of chickenpox vaccine in two 14-year-old boys who received both recommended doses, according to a paper published Wednesday in the journal Pediatrics.

27/11/2019

https://www.organicconsumers.org/news/amazon-admits-it-sold-fake-supplements?fbclid=IwAR2w2DlBLS_gPkGwH_nC9jbgceLsVS2KpwK7HmdGfpF-Am1XZGirS4DdtcI

Amazon runs an annual sale they've dubbed Prime Day, which ran July 15 and 16, 2019, for the U.S. On the second evening, as reported by Wired, Anne-Marie Bressler received an automated email from Amazon informing her that one of the nutritional supplements she'd ordered two weeks earlier were likely...

26/11/2019

https://www.statnews.com/2019/11/25/brain-boosting-supplements-contain-unapproved-drug/

The doctor who led the study worries that consumers could be taking a drug under no medical supervision at a dangerous dosage.

25/11/2019

We are happy to support this petition:
Please sign our petition and we are close to launching our project! - Valerie Lenie
https://www.change.org/.../a-demand-to-investigate-the...

Change.org is the web's leading platform for social change, empowering anyone, anywhere to start petitions that make a difference.

22/11/2019

*** Please share this with the Breast Implant Illness community as many of these recalled boxes have been sent out as samples to BII ladies! ***

FDA Glutadose Recall Enforcement Report can be found under “FDA Enforcement Report Search”:

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=173053

21/11/2019

Recall on stomach medicine ranitidine due to cancer-causing agents polluting this oral solution.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/precision-dose-inc-issues-voluntary-nationwide-recall-ranitidine-oral-solution-usp-150-mg10-ml-due?utm_campaign=FDA%20MedWatch%20-%20Ranitidine%20Oral%20Solution%20by%20Precision%20Dose%3A%20Recall&utm_medium=email&utm_source=Eloqua

Precision Dose Inc. is voluntarily recalling 5 lots of Ranitidine Oral Solution, USP 150 mg/10 mL to the consumer level. Ranitidine Oral Solution, USP 150 mg/10 mL, is being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

21/11/2019

https://www.washingtontimes.com/news/2019/nov/13/mold-outbreak-closes-all-seattle-childrens-operati/

21/11/2019

https://www.wthr.com/article/indiana-hospital-we-failed-disinfect-surgical-tools?fbclid=IwAR195R1jCR6bHs0qNvR4tm7__1E2gdhjVGvAgoOJR6S0plZZxmNBn5hqzp0

A northern Indiana hospital has alerted more than 1,000 surgery patients who may have been exposed to hepatitis, HIV and other infectious diseases due to a sterilization failure.

05/11/2019

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=3554277

To whom it may concern, i had an ultherapy treatment done for wrinkles under my eyes in mid (b)(6) 2013 by doctor (b)(6)'s office. Speaking as someone with a high threshold for pain ultherapy was the most painful experience i have ever had. My experience entailed an aesthetician mashing a rock hard....