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How to Slowly Taper Off Rx Psych Drugs 
More from the Board of Education

FDA Recalls and Removals

Duloxetine FDA Recall source: (i found it linked to an article from Montana news as a source:)

Product Details Product Description: Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.

Reason for Recall: CGMP Deviations:

Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Product

Quantity: 7,107 bottles

Recall Number: D-0009-2025

Code Information:

Lot #: 220128, Exp.

Date 12/2024 Classification:

Class II Event Details

Event ID: 95508

Voluntary / Mandated:

Voluntary: Firm initiated

Product Type: Drugs Initial Firm Notification of Consignee or Public:

Letter Status: Ongoing Distribution Pattern:

Product was distributed nationwide within the United States Recalling Firm:

Breckenridge Pharmaceutical, Inc 15 Massirio Dr Ste 201 Berlin, CT 06037-2352

United States Press Release URL(s): Press Release Not Issued For This Recall Recall Initiation Date: 10/10/2024

Center Classification Date: 10/11/2024

Date Terminated: N/A *N/A - Not Available

Update History Reason for Recall (last updated on 10/31/2024):

Previous Value:

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

New Value: CGMP Deviations:

Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Reason for Recall (last updated on 10/17/2024):

Previous Value: Failed Impurities/Degradation Specifications: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. New Value: CGMP Deviations:

Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. https://www.accessdata.fda.gov/scripts/ires/?Product=2104

Enter "Duloxetine" or other drugs to the FDA recall search to get to the list I found.

⚠ Alert FDA DRUG RECALL ALERT for Rx "Duloxetine" antidepressant (generic for "Cymbalta". "Nitrosamines" ☠

"Thousands of bottles of antidepressants have been recalled across the U.S. after they were found to contain levels of a potentially cancer-causing chemical above the acceptable limit as set out by the U.S. Food and Drug Administration.

The recall of the Duloxetine Delayed-Release Capsules, produced by Towa Pharmaceutical Europe, was initiated on October 10 and has been given the second highest risk classification by the FDA. Duloxetine is a medication used to manage depression, anxiety, and nerve pain, such as fibromyalgia. It works by increasing levels of mood-boosting chemicals in the brain.

However, during its production, low levels of a chemical called N-nitroso-duloxetine can also be produced. This chemical belongs to a group of chemicals called nitrosamines that are commonly found in water and food products.

However, when they are present in higher concentrations, and we are exposed to them for an extended period of time, these chemicals may increase our risk of developing cancer. As a result, their concentrations are strictly limited by the FDA.

"There are multiple reasons why nitrosamines can be present in drugs. FDA found the source of nitrosamines can be related to the drug's manufacturing process or its chemical structure or even the conditions in which they are stored or packaged," the FDA said in a statement.
"As foods and drugs are processed in the body, nitrosamines can also be formed.

FDA continues to test and research possible sources for drugs found to contain nitrosamines."

Source: FDA FEDERAL FOOD AND DRUG ADMINISTRATION
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cder-nitrosamine-impurity-acceptable-intake-limits?fbclid=IwY2xjawLmZg5leHRuA2FlbQIxMABicmlkETFSUk1FUm9LU3BTYURHc2d5AR5C6741SvUwZrEX2GHaUfGBmYvhgK_uGllWPOw_MnbJjP_R1g8kUPW55QCJNw_aem_vBr8QO0E3GL5O4ksxXNvhw

Cancer-Causing Chemical Spurs Second, Bigger Recall of Duloxetine Dec 12, 2024 https://www.oncologynewscentral.com/oncology/cancer-causing-chemical-spurs-second-bigger-recall-of-duloxetine?fbclid=IwY2xjawLmZvVleHRuA2FlbQIxMABicmlkETFSUk1FUm9LU3BTYURHc2d5AR7_8SaacG-dC97IBVUp8ojLsRIsozG5AXH8c5lCP05TcR2PoaLWswZYLhh4MQ_aem_VWkh4jsRD8ceRCjgtthYMg

Duloxetine Recall - FDA Source:
(Tiny text copied, for your convenience) 

"Product Details Product Description: Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.

Reason for Recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Product Quantity: 7,107 bottles

Recall Number: D-0009-2025
Code Information:
Lot #: 220128, Exp.
Date 12/2024 Classification:

Class II Event Details
Event ID: 95508

Voluntary / Mandated:
Voluntary: Firm initiated

Product Type: Drugs Initial Firm Notification of Consignee or Public:

Letter Status: Ongoing Distribution Pattern:

Product was distributed nationwide within the United States Recalling Firm:
Breckenridge Pharmaceutical, Inc 15 Massirio Dr Ste 201 Berlin, CT 06037-2352

United States Press Release URL(s):
Press Release Not Issued For This Recall Recall Initiation Date: 10/10/2024

Center Classification Date: 10/11/2024

Date Terminated: N/A *N/A - Not Available

Update History Reason for Recall (last updated on 10/31/2024):

Previous Value:
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

New Value: CGMP Deviations:
Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Reason for Recall (last updated on 10/17/2024):

Previous Value: Failed Impurities/Degradation Specifications: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

New Value: CGMP Deviations:

Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit." https://www.accessdata.fda.gov/scripts/ires/?Product=2104

Enter "Duloxetine" or other drugs to the FDA recall search to get to the list I found.

FDA: "According to the FDA, the medication had the "presence" of an impurity

– a potentially cancer-causing substance, or nitrosamine

– called N-nitrosoduloxetine, that exceeds the recommended limit.

The increased presence of this chemical "may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time."

I want to know if all antidepressants ... if all psych drugs have these ingredients too.
Try looking on the drug's warning leaflets legal disclaimers PHYSICIAN'S REFERENCE DOCUMENTS package inserts, on the last page.

Find common psych drug warning leaflets here, and let me know what you discover.

Use the best sources provided in this link, when researching and writing reports, and mail to all your doctors, pharmacists, lawyer. Thanks.

RX PSYCH DRUG AWARENESS:
https://mhanafromheaven.wixsite.com/rx-drug-awareness/drugwarnings

How to Slowly Taper Off Rx Psych Drugs 
More from the Board of Education

Parked School Buses

​US Board of Education 

"US Board of Education Advises Against Drugs for Behavioral Problems
 

A US board of education has passed a resolution urging teachers to use discipline and instruction to overcome problem behavior in the classroom, rather than encouraging parents to seek drug treatment for their children.
 

The resolution passed by Colorado Board of Education carries no legal weight but sounds a warning on the growing use of drugs such as Ritalin (methylphenidate hydrochloride) to deal with disruptive behavior in schools.

Board members supporting the resolution believed that many violent crimes committed by school students are committed by young people taking psychotropic drugs. In the massacre last spring at Columbine High School in Littleton, Colorado, one of the teenage shooters, Eric Harris, had been taking the antidepressant Luvox (fluvoxamine).

The board's action, believed to be the first in the United States, is sure to intensify the debate over the use of psychotropic drugs in conditions such as attention deficit hyperactivity disorder.
 

An estimated 2.5 million children in the United States are now taking drugs for this type of problem.


Dr Peter Breggin, director of the International Center for the Study of Psychiatry and Psychology, a non-profit research organization in Bethesda, MD, believes that doctors are overprescribing psychotropic drugs.

“It's a tremendous mistake to subdue the behavior of children instead of tending to their needs,” he said. He is convinced there is a direct link between the drugs and violent acts.

The use of psychotropic drugs in children with attention deficit hyperactivity disorder was examined last May in the Journal of the American Academy of Child and Adolescent Psychiatry.
 

A review of a sample of nearly 1300 children in four US communities showed an overall rate of the disorder of about 5%, based on formal diagnostic criteria."


Source: US Board of Education:

https://pmc.ncbi.nlm.nih.gov/articles/PMC1070779/
 

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