Counterfeit Medicine News for the Week of September 21, 2020

In PSM’s round-up this week: HHS defies 20 years of expertise and guidance and recent negative feedback to finalize regulations for state-based Canadian drug importation programs, forward movement on the Safe Therapeutics Act, and more #covidscam and counterfeit drug news.

[...]

Trump Administration Defies 20 Years of FDA Expertise and Guidance in Finalizing Politically Motivated Drug Importation Rule

Trump Administration Defies 20 Years of FDA Expertise and Guidance in Finalizing Politically Motivated Drug Importation Rule Washington, D.C. (September 24, 2020) – Shabbir Safdar, executive director of the Partnership for Safe Medicines, released the following statement in response to the Trump Administration’s Final Rule issued today on the importation of prescription drugs: “With 40…

[...]

September 9, 2020 video: 1,000 Fake Pills per bottle – a bust in Toronto

Last June, police in Ontario, Canada carried out Project Javelin, shutting down a huge counterfeiting operation that manufactured hundreds of thousands of fentanyl pills disguised as Oxycocet, a Health Canada-approved generic oxycodone and acetaminophen product with the same ingredients as Percocet.

Update: Executive Director Shabbir Safdar followed up with retired Chief Superintendent of the Ontario Police Don Bell to talk about the impact these criminals could have had. Watch that interview in our September 23rd video, “Deadly Pills in Ontario.”

[...]

FDA Alert: Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. To date, Acella has received four reports of adverse events for these lot numbers possibly related to this recall.

[...]

RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid® and WP Thyroid® with Current Expiry Due to Sub Potency

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid® or WP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.

[...]