Recall reported for Safety Issues

H&Natural Brand Products - recalled due to Yellow oleander, USA

2 months ago •source www.fda.gov

Recall notice

San Luis, AZ, G.A. Mart dba H&Natural, is voluntarily recalling 2 lots of H&NATURAL TejoRoot, 10g pills, and 2 lots of H&NATURAL Brazil Seed, .167g Seeds to the consumer level. The products have been found via random FDA testing to contain yellow oleander, a poisonous plant native … See More

to Mexico and Central America. H&NATURAL TejoRoot and H&NATURAL Brazil Seed were distributed Nationwide to via internet on their site, Amazon.com, and Walmart.com. The company has received one report of gastrointestinal illness, including painful symptoms in conjunction with internal bleeding in connection with H&NATURAL TejoRoot, and has not received any reports of adverse events in connection with H&NATURAL Brazil Seed.

Risk Statement: Ingestion of yellow oleander can cause neurologic, gastrointestinal, and cardiovascular adverse health effects that may be severe, or even fatal. Symptoms may include nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac changes, dysrhythmia, and more.

The recalled dietary supplements can be identified by the H&NATURAL logo and the following descriptions:
- Tejo Root, Raiz de Tejocte, H&Natural, Healthy, and Natural, Dietary Supplement, 10g pills, is packaged in a box or bottle, with UPC (196852946921)
- Brazil Seed Pure Natural Semilla de Brasil, H& Natural, Healthy and Natural, 0.167g seeds, packaged in a box or bottle, with UPC (195893047529) (196852820641) (195893698721) (195893236893)(196852134618) (195893336975)

Recalled lots are labeled with the following expiration dates, 3/24 and 5/24.

Consumers that have the recalled H&NATURAL TejoRoot or H&NATURAL Brazil Seed lots should stop using the products. 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 extraneous materials, 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: G.A. Mart dba H&Natural
Brand name: H&Natural
Product recalled: Brazil Seed Pure Natural Semilla de Brasil & Tejo Root, Raiz de Tejocte
Reason of the recall: Product contains yellow oleander, a poisonous plant
FDA Recall date: February 23, 2024

Source: www.fda.gov

#amazon #walmart #dietarysupplements #recall #us

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Nordic Naturals Baby’s Vitamin D3 - recalled due to Elevated level of Vitamin D3 dosage, USA

2 months ago •source www.fda.gov

Recall notice

Nordic Naturals is voluntarily recalling one lot of Nordic Naturals Baby’s Vitamin D3 Liquid. This recall is being conducted due to a manufacturing error that resulted in an elevated level of Vitamin D3 dosage or super potent dose. There have been no reports of adverse events to … See More

#dietarysupplements #recall #us

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Sustain and Schwinnng male enhancement capsules - recalled due to undeclared Tadalafil and Nortadalafil, USA

2 months ago •source www.fda.gov

Recall notice

“Today The World” is voluntarily recalling two lots of Sustain herbal dietary supplement capsules and one lot of Schwinnng capsules to the consumer level. FDA analysis has found the products to contain undeclared Tadalafil and Nortadalafil. Products were distributed online nationwide in the USA. To date, no … See More

adverse events have been reported.

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.

Risk Statement: Consumption of products with undeclared tadalafil or nortadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.

These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged and coded as follows:
SUSTAIN: BTH: 230551 having EXP:12.05.2026, BTH: 230571 having EXP: 14.05.2026 SCHWINNNG Lot 2108 having EXP 10/2024.

The World is notifying its customers by this press announcement of this recall release and is arranging for return/replacement etc. of all recalled products. Consumers that have Sustain or Schwinnng which is being recalled should stop using and return if desired to Today The World. The Sustain and Schwinnng products must include the blister pack foil (with any pills remaining) containing all lot codes and receipt of proof of purchase, and your return address.

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 experienced harm from allergens or undeclared ingredients, 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: Today the World
Brand name: Sustain, Schwinnng
Product recalled: Sustain and Schwinnng brand male enhancement capsules
Reason of the recall: Products contain undeclared Tadalafil and Nortadalafil
FDA Recall date: February 05, 2024

Source: www.fda.gov

#recall #drugs #us

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Arize male enhancement capsules - recalled due to undeclared Nortadalafil, USA

2 months ago •source www.fda.gov

Recall notice

"Today The World” is voluntarily recalling one lot of Arize Herbal Dietary Supplement capsules to the consumer level. FDA analysis has found the products to contain undeclared Nortadalafil. The product was distributed online via their website in the USA. To date, no adverse events have been reported. … See More

#recall #drugs #us

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Covidien and Cardinal Health Urology and room kits and trays Update - recalled due to potential lack of sterility assurance, USA

2 months ago •source www.fda.gov

Recall notice

Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology and operating room-specific kits and … See More

trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied by Nurse Assist. Under the Nurse Assist voluntary recall, this product is being recalled due to the potential for a lack of sterility assurance which could result in non-sterile product. There have been no reports of patient harm.

In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.

After reviewing the impact of the Nurse Assist recall, Cardinal Health has identified the affected Covidien and Cardinal Health™ brand codes and lot numbers, which you can see in the link below. Customers who received the listed lots were given instructions to:
1. QUARANTINE affected kits/trays.
2. ALERT clinicians of the recalled component(s).
3. AFFIX a WARNING LABEL to the front of each kit/tray so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s).
4. NOTIFY other departments, facilities or customers within the customer’s hospital system, if they have transferred the affected kits/trays, and provide a copy of the notice and recall acknowledgement form to them.
5. RETURN their enclosed Acknowledgment Form confirming receipt of this action and the completion of over labeled 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: Cardinal Health
Brand name: Covidien and Cardinal Health
Product recalled: Expanded list of Urology and OR room specific kits and trays
Reason of the recall: Potential lack of sterility assurance which could result in non-sterile product
FDA Recall date: February 05, 2024

Source: www.fda.gov

#medicaldevices #recall #us

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TING® 1% Tolnaftate Athlete’s Foot Spray recalled due to Benzene presence, USA

2 months ago •source www.fda.gov

Recall notice

Insight Pharmaceuticals is voluntarily recalling two lots of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid to the consumer level due to elevated levels of benzene. The affected TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid lots were distributed nationwide in the United States through … See More

a limited number of retailers and online. No serious adverse events have been reported to date.

TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid is packaged in blue and white aerosol cans with Lot codes located on the bottom of the can. Samples of the recalled lots below have been found to contain elevated levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Ting products.

- Product: TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid, NDC: 63736-819-05, Lot Number: 0H50545, Expiration Date: 07/24, Package Size: 4.5 oz/128 g.
- Product: TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid, NDC: 63736-819-05, Lot Number: 1G50645, Expiration Date: 06/25, Package Size: 4.5 oz/128 g.
Insight has notified retailers via overnight mail to remove any remaining recalled product from shelves and follow the instructions provided in the Drug Recall Notification. The company will also offer reimbursement for consumers who have purchased TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid marked with one of the lot codes in the table above.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. Insight is recalling these products out of an abundance of caution. To date, the Company has not received any serious adverse events related to this recall. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.

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: Insight Pharmaceuticals
Brand name: TING®
Product recalled: 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid
Reason of the recall: Presence of benzene
FDA Recall date: February 02, 2024

Source: www.fda.gov

#recall #drugs #us

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Neptune’s Fix, Fix Elixir, Fix Extra Strength Elixir & Fix Tablets - recalled due to undeclared tianeptine, USA

2 months ago •source www.fda.gov

Recall notice

Neptune Resources, LLC issues a voluntary recall of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets Products Due to the Presence of Tianeptine. The products were distributed nationwide in the USA to wholesale and retail customers. Neptune Resources LLC's distribution channels have not … See More

reported any adverse events from the use of its products.

The FDA has advised that: There is a reasonable probability of life-threatening events including suicidal ideation or behavior for children, adolescents, and young adults 25 and younger. In addition, individuals could unintentionally overdose and experience serious and potentially life-threatening risks including confusion, seizures, drowsiness, dry mouth, and shortness of breath, which may be exacerbated by alcohol use. Further, the risks of adverse effects associated with use of tianeptine along with antidepressants, known as monoamine oxidase inhibitors (MAOls), are potentially serious and life-threatening.

Neptune's Fix Elixir and Extra Strength Elixir are used as a supplement and are packaged in amber glass bottles with a "shrink sleeve" label that covers the entire cap/bottle and is perforated at the cap to facilitate opening. Neptune's Fix tablets are packaged in 20-count blister packs held in small boxes or 4-count foil packets. All Neptune's Fix products are being recalled. The product can be identified by the name Neptune's Fix and its logo which is an illustration of the Roman God Neptune with a green beard and a trident.

Neptune Resources is notifying its distributors and customers by form of a mailed out recall letter and is arranging for the return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using it and return it to place of purchase immediately.

In case you experience harm from allergens or undeclared ingredients, 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: Neptune Resources, LLC
Brand name: Neptune’s Fix
Product recalled: Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets
Reason of the recall: Undeclared Tianeptine
FDA Recall date: January 29, 2024

Source: www.fda.gov

#recall #drugs #us

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Zendedi dextroamphetamine sulfate tablets - recalled due to mislabeled package, USA

3 months ago •source www.fda.gov

Recall notice

Azurity Pharmaceuticals, Inc. is voluntarily recalling one lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi® 30 mg tablets and found … See More

tablets of Carbinoxamine Maleate, an antihistamine drug. The product was distributed nationwide through pharmacies. To date, Azurity has not received any reports of serious adverse events related to this recall.

Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury. Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder. For patients with Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy (sleep disorder) there is a reasonable probability that accidents or injuries that occur due to the sedating effects of carbinoxamine, could lead to ongoing disability or death in severe cases, particularly if individuals who use it (unaware that they have not received Zenzedi®) engage in activities requiring significant focus and alertness (e.g., driving, operating heavy machinery).

Zenzedi® is a prescription medicine for the treatment of Narcolepsy. Zenzedi® is also indicated as a treatment for attention deficit hyperactivity disorder (ADHD). Zenzedi® is marketed under Arbor Pharmaceuticals, LLC brand. Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc.

Zenzedi® 30 mg tablets can be identified by light yellow hexagonal tablet debossed with “30” on one side and “MIA” on the other side and distributed in a white bottle with black writing and “30 mg” highlighted yellow. Whereas the description of the suspect tablets (Carbinoxamine Maleate Tablets USP, 4 mg), which was provided by the reporting pharmacist, was white round tablets with imprints of “GL” on one side and “211” on the other side. Following are the details of the recalled product:

- Product: Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg, NDC No.: 24338-856-03, Lot No.: F230169A, Exp. Date: 2025-06, Ship Dates to Wholesalers: 08/23/2023 – 11/29/2023.

Azurity Pharmaceuticals, Inc. sent recall notification letters via overnight delivery to wholesale distributors on January 4, 2024, and arranged for the return of all recalled products at that wholesaler level. Consumers who have a product that is being recalled should stop using and return to place of purchase. Azurity is working with wholesalers and retailers to arrange for the return and replacement of recalled product.

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: Azurity Pharmaceuticals, Inc.
Brand name: Zendedi
Product recalled: dextroamphetamine sulfate tablets, 30 mg
Reason of the recall: Mislabeled package
FDA Recall date: January 25, 2024

Source: www.fda.gov

#recall #drugs #us

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Robitussin Cough syrups - recalled due to microbial contamination, USA

3 months ago •source www.fda.gov

Recall notice

Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination. To date, Haleon has not received any reports of adverse events related to this … See More

#recall #drugs #us

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Aligned Medical Solutions Convenience kits containing saline - recalled due to safety concerns, USA

3 months ago •source www.fda.gov

Recall notice

Aligned Medical Solutions, initiated a nationwide recall of Convenience kits containing saline because the Product cannot be verified as having the required sterility assurance level. Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit. Aligned Medical Solutions distributed these kits … See More

nationwide in the USA. Recalled Product(s) were manufactured from 06/028/2022 to 11/20/23 and distributed from 06/08/2022 to 11/27/2023. No injuries have been reported to date.

Water-based medical products that are nonsterile and potentially contaminated with bacteria could cause serious or life-threatening infections. Patients who are elderly, critically ill, have weak immune systems (including newborn infants, pregnant women, and cancer patients), or have chronic diseases are particularly at risk of infection. However, other patients could also develop infections after they are exposed to contaminated water-based medical products.

Recalled products apply to the following kits: AMS10833 Local Lower Extremity Pack I, AMS12947 In-House Ocular Pack, AMS12947A In-House Ocular Pack, and AMS13043 Closure Kit. Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit. Details are attached.

These convenience kits contain the recalled Nurse Assist Sterile Saline, Brand Name - Medline Medical part # DYND40540 110ML Sterile Saline Cup or Nurse Assist Sterile Saline Brand Name - McKesson Medical part # 560284 100ML Sterile Saline Bottle, which has been recalled because the Nurse Assist product cannot be verified as having the required sterility assurance level (SAL) of 10-6. See Nurse Assist Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation

Customers who have affected products should immediately review their inventory and quarantine all affected kits. Contact the Quality Department for further instructions on labeling and replacement products if needed. Customers will be provided with a label that is to be placed on the packs containing the recalled Nurse Assist Sterile Saline. Aligned Medical Solutions is notifying its distributors by email and will arrange for labels to identify the packs with the recalled sterile saline. At the time the kit is opened for use, Nurse Assist sterile saline should be identified, and quarantined according to the medical waste policies in effect in your institution. All other components in the kit are not affected by this recall. Aligned Medical Solutions will also arrange for replacement sterile saline to be sent for all recalled product[s].

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: Aligned Medical Solutions
Brand name: Aligned Medical Solutions
Product recalled: Convenience kits containing saline
Reason for the recall: The product cannot be verified as having the required sterility assurance level
FDA Recall date: January 23, 2024

Source: www.fda.gov

#recall #medicaldevices #us