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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Tri-Ton by Dynamic Technical Formulations, LLC: Recall - Contains Andarine and Ostarine Drug Ingredients
AUDIENCE: Consumer
ISSUE: Dynamic Technical Formulations LLC. is voluntarily recalling all lots of Tri-Ton. This product was sold in 90 count bottles as a dietary supplement and includes all lot number and expiration dates of the product. FDA lab analysis of Tri-Ton was found to contain andarine and ostarine which are selective androgen receptor modulators (SARMs) that are considered unapproved drugs and anabolic steroid-like substances.
Use or consumption of products containing SARMs and anabolic steroid-like substances may cause acute liver injury, which is known to be a possible harmful effect of using steroid containing products. In addition, abuse of anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death
BACKGROUND: This product was sold in 90 count bottles through retailers nationwide. Shipment of this product was from June 2016 to March 2017
RECOMMENDATION: Consumers should stop using the product immediately and throw it away in accordance with your state and local ordinances for disposal of drug products or return the unused portion of product for a refund. Consumers with questions regarding this recall can contact Dynamic Technical Formulations by emailingcustomerservice@dtformulations.com or calling 800-331-6723 from 9:00am to 5:00pm EST.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online:www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the press release, at:
Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention
Including:
Ablavar (gadofosveset trisodium)
Dotarem (gadoterate meglumine)
Eovist (gadoxetate disodium)
Gadavist (gadobutrol)
Magnevist (gadopentetate dimeglumine)
MultiHance (gadobenate dimeglumine)
Omniscan (gadodiamide)
OptiMARK (gadoversetamide)
ProHance (gadoteridol)
Dotarem (gadoterate meglumine)
Eovist (gadoxetate disodium)
Gadavist (gadobutrol)
Magnevist (gadopentetate dimeglumine)
MultiHance (gadobenate dimeglumine)
Omniscan (gadodiamide)
OptiMARK (gadoversetamide)
ProHance (gadoteridol)
AUDIENCE: Radiology
ISSUE: An FDA review to date has not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). All GBCAs may be associated with some gadolinium retention in the brain and other body tissues. However, because FDA identified no evidence to date that gadolinium retention in the brain from any of the GBCAs, including GBCAs associated with higher retention of gadolinium, is harmful, restricting GBCA use is not warranted at this time. FDA will continue to assess the safety of GBCAs and plan to have a public meeting to discuss this issue in the future.
FDA evaluated scientific publications and adverse event reports submitted to FDA. Some human and animal studies looked at GBCA use over periods longer than a year. These publications and reports show that gadolinium is retained in organs such as the brain, bones, and skin. The publications show that linear GBCAs retain more gadolinium in the brain than macrocyclic GBCAs. However, the review did not identify adverse health effects related to this brain retention.
FDA continues to assess the safety of GBCAs. FDA’s National Center for Toxicological Research is conducting a study on brain retention of GBCAs in rats. Other research is also being conducted about how gadolinium is retained in the body. FDA will update the public when new information becomes available and we plan to have a public meeting to discuss this issue in the future.
BACKGROUND: Gadolinium-Based Contrast Agents are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging or magnetic resonance angiography.
RECOMMENDATION: FDA recommendations for health care professionals and patients remain unchanged from July 2015 when FDA informed the public that FDA was investigating this potential risk with GBCAs. As is appropriate when considering the use of any medical imaging agent, health care professionals should limit GBCA use to circumstances in which additional information provided by the contrast agent is necessary, and assess the necessity of repetitive MRIs with GBCAs. Patients, parents, and caregivers should talk to their health care professionals if they have any questions or concerns about the use of GBCAs with MRIs. Retention of gadolinium affects only GBCAs, and does not apply to other types of scanning agents used for other imaging procedures, such as those that are iodine-based or radioisotopes.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online:www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
V60 Non-invasive Ventilator by Respironics: Class I Recall - Unexpected Device Shut Down
AUDIENCE: Risk Manager, Nursing, Pulmonology, Critical Care Medicine
ISSUE: Respironics is recalling the V60 Non-invasive Ventilator because the pins within the internal cable that connects the ventilator's motor to the control board may become loose over time due to low frequency vibration. The loose pins may prevent data to be transferred between the motor and the control board, triggering the ventilator to shut down unexpectedly and to sound an alarm. An unexpected stop in ventilation therapy may cause serious adverse health consequences, including death.
- See the Recall Notice for a listing of affected serial numbers
- Manufacturing dates: April 2, 2009 to September 15, 2015
- Distribution dates: April 4, 2009 to September 14, 2015
BACKGROUND: The Respironics V60 Non-invasive Ventilator provides continuous or intermittent breathing support to pediatric patients weighing at least 44 pounds to adult patients. This ventilator is used in hospitals or other health care facilities under the direction of qualified medical professionals such as physicians, nurses, and respiratory therapists.
RECOMMENDATION: On May 8, 2017, Respironics California sent an "Urgent: Medical Device Recall" letter to its consumers. The letter provided the following information to customers:
- Appropriately trained personnel may continue using the V60. The incidence of failure is low.
- Ensure an alternative form of ventilation is available at all times, including intra-hospital transport (e.g. manual ventilation bag).
- Operate the ventilator as directed in the operator's manual including:
- promptly attend all alarms presented by the ventilator;
- use an external oxygen monitor, and to set the alarm thresholds appropriately;
- ensure the correct circuits and masks identified in the operator's manual are being used;
- When possible, connect the ventilator to a remote call system.
- If the V60 shuts down, alarms, and displays any of the error codes 100A, 1006, 1007, 1008:
- turn the V60 off
- discontinue use of the V60
- use an alternate ventilator
- call your local customer service contact and report the failure by referencing FCO86600037A.
Health care professionals and consumers with questions about this device are instructed to contact Respironics California at 1-800-345-6443.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online:www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA recall notice, at:
05/18/2017 05:22 PM EDT
BrightFarms is initiating a voluntary recall of packaged produce sold in Giant Food stores due to the potential presence of metal as a result of construction at its Elkwood, Virginia (Culpeper County) greenhouse farm.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
05/19/2017 07:08 PM EDT
Dynamic Technical Formulations LLC. is voluntarily recalling all lots of Tri-Ton. This product was sold in 90 count bottles as a dietary supplement and includes all lot number and expiration dates of the product. The US Food and Drug Administration (FDA) lab analysis of Tri-Ton was found to contain andarine and ostarine which are selective androgen receptor modulators (SARMs) that are considered unapproved drugs and anabolic steroid-like substances.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
