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Launch Sequence Aphrodisia and Euphoria Capsules - recalled due to contain Tadalafil, USA

1 year ago

United States

Hauppauge, NY, Loud Muscle Science, LLC is voluntarily recalling the following Launch Sequence products and lots listed in the table below to the consumer level. Laboratory analysis undertaken at the request of Loud Muscle Science, LLC found the products to be tainted with tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in the Launch Sequence products makes these products unapproved drugs for which the safety and efficacy have not been established and therefore, subject to recall.

Risk Statement: The most critical potential adverse health consequence of unintentional consumption of a product tainted with undeclared tadalafil is profound, life-threatening hypotension related to drug-drug interactions with nitroglycerin or guanylate cyclase inhibitors.

In the expected-use population, profound hypotension can result in a heart attack, stroke or death. To date, Loud Muscle Science has not received any reports of adverse events related to this recall. These tainted Launch Sequence Capsule products are marketed as dietary supplements for male sexual enhancement. The affected products are:

- Launch Sequence Capsules. Package Size: 60. (Bottle) ASIN: B07TLPWXDS. UPC Code: 641378938375.
- Launch Sequence Euphoria Capsules. Package Size: 10. (Tin) ASIN: B08ZJX4V9J. UPC Code: 661020846864.
- Launch Sequence Aphrodisia Capsules. Package Size: 4. (Tin) ASIN: B07QB3S2LV. UPC Code: 661020846957.
- Launch Sequence Capsules. Package Size: 60. (Bottle) ASIN: B08HM7VHCX. UPC Code: 661020848166.
- Launch Sequence Euphoria Capsules. Package Size: 10. (Tin) ASIN: B08ZJX4V9J. UPC Code: 661020846864.
- Launch Sequence Aphrodisia Capsules. Package Size: 4. (Tin) ASIN: B09S12VK3F. UPC Code: 661020846957.

The full list of lots and expiry dates is available at the link below. The Launce Sequence capsule products were sold under Amazon ASIN Nos. B07TLPWXDS (USA 60 count) and B08HM7VHCX (Canada 60 count); Launch Sequence Euphoria capsule products were sold under Amazon ASIN Nos. B08ZJX4V9J (Euphoria USA 10 count) and B08ZJX4V9J (Euphoria Canada 10 count); and Launch Sequence Aphrodisia capsule products were sold under Amazon ASIN Nos. B07QB3S2LV (Aphrodisia USA 4 count) and B09S12VK3F (Aphrodisia Canada 4 count).

The products can be identified by the labels and packaging below. The product was marketed via the Internet and fulfilled by Amazon at www.amazon.com Nationwide in the USA and www.amazon.ca in Canada, on eBay.com, and in retail stores.

Loud Muscle Science is notifying its distributors and customers by letter and this press announcement and providing a refund to its customers. Consumers that have the Launch Sequence products should stop using the product and discard.

Consumers with questions regarding this recall can contact Loud Muscle Science, LLC by phone number: 631-270-4188 -- Monday through Friday 9AM – 4PM EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Company name: Loud Muscle Science, LLC
Brand name: Launch Sequence
Product recalled: Launch Sequence Aphrodisia and Euphoria Capsules
Reason of the recall: Contain Tadalafil
FDA Recall date: June 30, 2022

Source: fda.gov

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Consumers are advised to consult their healthcare provider if they have any health concerns related to this recall.

Return affected product to your local pharmacy or place of purchase. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.

If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

Source: recalls-rappels.canada.ca
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Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs, or brain which can cause stroke and even lead to death.

Treprostinil Injection is formulated for subcutaneous or intravenous infusion. The product is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require a transition from epoprostenol to reduce the rate of clinical deterioration.

Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. Only Lot 57014, expiration date 04/2024 is affected by this recall. Vials from the affected lot bear the attached label.

Par is providing written notification to wholesale accounts and the hospital location that has received the affected lot and is arranging for the return of all existing inventory of Lot 57014 through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue the use and stop distribution immediately.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Endo International, Par Pharmaceutical
Brand name: Par Pharmaceutical
Product recalled: Treprostinil 20mg/20mL Injection
Reason for the recall: Potential Presence of Silicone Particulate Matter
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Source: fda.gov
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For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potentially heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.

The affected products are:
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- Product Name: Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid, Wheat Germ Oil), Package Description: 3.5-gram tube, packaged in a cardboard box, Brand Name: Equate, NDC: 79903-028-35, UPC Code: 681131395304.
- Product Name: CVS Health Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid Wheat Germ Oil, Package Description: 3.5-gram tube, packaged in a cardboard box, Brand Name: CVS Health, NDC: 76168-707-35, UPC Code: 050428634141.
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For Lot number and expiry dates, you can visit the link below.

Brassica Pharma Pvt. Ltd. Is notifying its distributors AACE Pharmaceuticals Inc and its retailers Walmart and CVS. These distributors shall be further notifying the wholesalers and retailers via mail of this recall and arranging for return of all impacted products listed above. Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled Eye Ointment and may return any of the above listed products to the place of purchase.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Brassica Pharma Pvt. Ltd.
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Source: fda.gov
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Tadalafil and Nortadalafil (structurally similar to Tadalafil) are active drug ingredients known for treatment of male erectile dysfunction. The presence of Tadalafil and Nortadalafil in Sustain capsules and Schwinnng capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

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