Injectable HRT Recalled Due to Sterility Assurances

Holy Hormones Journal:  In a press release issued on July 31, 2013 Beacon Hill Medical Pharmacy d/b/a/ Rxtra Solutions (Beacon Hill) voluntarily recalled all lots of 135 of its sterile injectables and hormone replacement therapy (HRT) products to the user level.  According to the FDA, there is an issue of sterility assurance for the affected products.

hgh-injections-costMicrobial contamination of products intended to be sterile can lead to serious infections, which may be life-threatening. Beacon Hill has not received any reports of adverse events related to this recall and to date, there is no evidence of contamination in the recalled products or any previously prepared products.

Although there are no reports – contamination – is a serious issues and is a by product in the manufacturing process of biologic medicines and vaccines.  According to Dr. Hanan Polansky of the Center for the Biology of Chronic Disease – these issues pose a serious health risk to medical consumers. The foreign fragments can actually be the cause of many diseases.

When we understand nature, chaos turns into order, fear into confidence, and disease into health.
-Hanan Polansky, author of Microcompetition with Foreign DNA and the Origin of Chronic Disease

“Nutrition should be the primary treatment – medication the supplement.”
-Bonnie Kaplan PhD

“You can trace every disease to a mineral deficiency.”
-Dr. Linus Pauling, double Nobel Laureate

“‘Femaleness’  was considered to be a mental illness that required constant management.”
-Holly Grigg-Spall, author of “Sweetening the Pill Or How We Got Hooked on Hormonal Birth Control”

These are three important statements that need to be incorporated into our way of thinking. Otherwise not only do we open ourselves up to further deterioration of our health with the use of synthetic hormones – but we may also be further sickened by undetected contamination of the product.  Beacon Hill has had no reports of ‘contamination’ is a misnomer.  How many medical consumers would even know to link their ‘new medical condition’ to product contamination.  None. Zippo. Never even disclosed as a possibility.

Remember when you read the article below – that there are many menstrual advocates who are actively protesting the medicalization of menstruation, menopause, and postpartum depression.  They are not diseases.

Make sure you read the article and look at this list of ‘potential’ side effects of HRT. And then weigh in your mind if hormone balance with the use of nutrition is better than masking the symptoms with synthetic hormones.

Hormone Therapy – Practice Essentials

August 19, 2013

Hormone therapy (HT) involves the administration of synthetic estrogen and progestogen to replace a woman’s depleting hormone levels and thus alleviate menopausal symptoms. However, HT has been linked to various risks; debate regarding its risk-benefit ratio continues.

Essential update: Sterility concerns prompt recall of injectables and HRT products

In July 2013, following FDA concerns about sterility assurance, Beacon Hill Medical Pharmacy, dba Rxtra Solutions, voluntarily recalled all nationwide lots of 135 of its sterile injectables and hormone replacement therapy (HRT) products.The recalled products are prescribed to patients receiving intravenous solutions and HRT. A complete list of the recalled products and further information can be found in the company’s press release.

Signs and symptoms

The spectrum and intensity of perimenopausal and menopausal symptoms vary greatly due to the effect of decreased circulating levels of estrogen on various organ systems.

The most common presentation of menopause (60% of postmenopausal women) is hypothalamically mediated vasomotor instability leading to hot flashes (hot flushes), sweating, and palpitations. Other common presenting symptoms include the following:

  • Irregular menstrual cycles
  • Urogenital symptoms: Vaginal dryness, soreness, superficial dyspareunia, urinary frequency and urgency
  • Neurologic symptoms: Mood changes, insomnia, depression, anxiety

Menopausal effects

Menopause has the following physiologic effects:

  • Vasomotor system: Vasomotor instability
  • Urogenital system: Atrophy and thinning of the mucosal lining of the urethra, urinary bladder, vagina, and vulva; loss of vaginal elasticity and distensibility; reduced vaginal secretions; degeneration of subepithelial vasculature and the supporting subcutaneous connective tissue
  • Bone metabolism: Progressive bone loss
  • Cardiac function: Increased susceptibility to heart disease

Read full article…

FDA: Recalls, Market Withdrawals & Safety Alerts


Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.