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Recall

Updated: March 14, 2024 8:48 AM
Several brands of folic acid tablets have been recalled in Canada due to concerns that affected lots may exceed the acceptable intake limit for N-nitroso-folic acid. The recall involves multiple brands distributed across the country.

-Affected products
Brand: Compliments FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG,... See More Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NHH
Brand: Equate FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115LRJ & 2G3115NHF
Brand: Health One FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NJL
Brand: Nature's Bounty FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2340T8130A
Brand: Pharmasave FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NHG
Brand: Sisu FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115M1C

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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Central Valley Ag Cooperative has voluntarily recalled its GS Hamster/Gerbil + Turmeric food due to a potential Salmonella contamination. The recall affects both animals and humans and is currently ongoing. The recalled product has been distributed in Kansas.

The recalled product is GS Hamster/Gerbil + Turmeric, sold... See More in bulk super sacks. A total of 7,464 pounds of the product, bearing the lot number B0624179808 11399 OXBOW and a best before date of 2/6/2026, have been recalled.

The recall was initiated after an ingredient in the gerbil/hamster feed tested positive for Salmonella.

The issue was discovered during routine testing by the company. The recall was initiated on February 26, 2024.

In case you are experiencing Salmonella symptoms such as diarrhea, abdominal cramps, and fever, it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source: accessdata.fda.gov
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Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product... See More solution. The lot was distributed nationwide to wholesalers and hospitals from June 16, 2022, through October 17, 2022. To date, Par has not received any reports of adverse events related to this recall.

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
FDA Recall date: March 12, 2024

Source: fda.gov
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Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA... See More SOFT pads were used. These reports of patient burn injuries described up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.

Since that notification, we have continued to monitor device performance through post market surveillance, investigated every event reported and evaluated potential root cause of these events. Megadyne recently received a report of pediatric use that included a serious 3rd degree patient burn. We are providing this additional broad public communication to increase awareness that MEGADYNE™ MEGA SOFT™ Universal and Universal Plus products should not be used for patients under the age of 12 years.

The list below contains the specific product and codes in scope.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Patient Return Electrode, Product Code: 0845, UDI-DI: 10614559103906.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Dual Patient Return Electrode, Product Code: 0846, UDI-DI: 10614559104248.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Patient Return Electrode, Product Code: 0847, UDI-DI: 10614559104842.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Dual Patient Return Electrode, Product Code: 0848, UDI-DI: 10614559104859.

Customers should review and follow the instructions provided in the December 2023 recall notification (link given below). Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes pads may continue to be used for patients over 12 years of age.

Confirm that personnel using the Mega Soft Universal and Universal Plus pads understand the intended use is changing to patients aged 12 years and older and have stopped using the pads on patients under the age of 12 years. Hospitals using this product should confirm receipt of the recall notification using the business reply form provided with the initial recall notification.

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: Megadyne Medical Products, Inc.
Brand name: Megadyne
Product recalled: Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes
Reason for the recall: Limit use to patients aged 12 years or older.
FDA Recall date: February 29, 2024

Recall link of December 2023: jnjmedtech.com
Source: fda.gov
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Avanos Medical, Inc. voluntarily recalled specific lots of MIC* Gastric – Jejunal Feeding Tube Kits on Jan. 16, 2024. These kits include Nurse Assist supplied syringes, pre-filled with sterile water, essential for inflating the retention balloon of the feeding tube. This recall initiated in direct response to... See More the Nurse Assist, LLC voluntary recall of pre-filled syringes and other sterile water products which was promtpted due to concerns about the potential lack of sterility assurance. Avanos has not been directly contacted with any reported adverse events.

This deficiency may lead to non-sterile products, posing a risk of the water coming into contact with a patient’s surgical site. Any open wound exposed to non-sterile products could potentially put the patient at risk of infection. The pre-filled syringe is the only item in the Avanos feeding tube kit affected by the Nurse Assist recall.

As of Feb. 6, 2024, the FDA reported receiving adverse events associated with use of Nurse Assist products and is further evaluating this information.

Upon evaluating the impact of the Nurse Assist recall, Avanos has identified the affected MIC* Gastric – Jejunal Feeding Tube Kit product codes and lot numbers. Customers receiving the listed lots are instructed to remove all affected kits from facilities and requested to take the following actions:

- Continue normal post-op care for any newly placed MIC* GJ tube.
- Report any adverse events involving these products immediately.
- Check all storage facilities and warehouse locations for affected products and quarantine them.
- Destroy all affected lots in inventory.
- Notify other departments or customers of this recall.

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: Avanos Medical, Inc.
Brand name: Avanos Medical
Product recalled: MIC* Gastric-Jejunal Feeding Tube Kits
Reason of the recall: Potential Lack of Sterility Assurance
FDA Recall date: February 27, 2024

Source: fda.gov
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Brassica Pharma Pvt. Ltd. is voluntarily recalling the Eye Ointment products listed below with expiration dates ranging from February 2024 to September 2025. The products are being recalled due to a lack of sterility assurance. These products were distributed nationwide to wholesalers, retailers, and via the product... See More distributors, Walmart, CVS, and AACE Pharmaceuticals Inc. To date, Brassica Pharma Pvt. Ltd. has not received any reports of adverse events up to 16th February 2024 related to this recall.

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:
- Product Name: Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%, Lanolin Alcohols), Package Description: 3.5-gram tube, packaged in a cardboard box, Brand Name: Equate, NDC: 79903-026-35, UPC Code: 681131395298.
- 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.
- Product Name: Lubricant PM Ointment, Package Description: 3.5-gram tube, packaged in a cardboard box, Brand Name: AACE Pharmaceuticals, NDC: 71406-124-35, UPC Code: 371406124356.
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.
Brand name: Multiple brands
Product recalled: Eye ointment products
Reason of the recall: Due to Potential Lack of Sterility Assurance.
FDA Recall date: February 26, 2024

Source: fda.gov
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Backstage Center is issuing a recall of approximately 280 Bottles of Alipotec Raiz de Tejocote, dietary supplements, that are labeled with the "Alipotec King" sticker. This recall is being initiated because FDA analysis found that the product contains toxic yellow oleander. The product has been exclusively distributed... See More on Amazon.com since September 15, 2023. There have been no reports of injury or illness, to date.

The recalled product, which contains yellow oleander instead of tejocote, may induce serious neurologic, gastrointestinal, and cardiovascular adverse health effects. Symptoms may be severe or fatal, including nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac dysrhythmia, and others. Immediate medical attention is advised for consumers experiencing such symptoms.

Product Name: Alipotec King, Alipotec Raiz de TejocoteContainer
Description: Cylindrical bottle with a green top, white body, and contains approximately 30 granules, weighing a total of 0.35oz.
Lot Codes: 238124
Expiration date: 08-2027
Total Distributed: 280 Bottles
Consumer Instructions: Consumers should immediately discontinue use of the 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: Backstage Center
Brand name: Alipotec King
Product recalled: Alipotec Raiz de Tejocote
Reason of the recall: Product contains yellow oleander, a poisonous plant
FDA Recall date: February 23, 2024

Source: fda.gov
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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: fda.gov
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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 date related to the use of this recalled product.

The recalled lot of Nordic Naturals Baby’s Vitamin D3 Liquid is 0.76 fl. oz. (22.5 mL), 400 IU (10mcg) D3. The affected lot number is 234909, with an expiration date of December 2025. The affected product is used as a dietary supplement for infants up to 12 months of age and is packaged in boxes containing one bottle and one dropper for dosage, under SKU RUS-02733. Approximately 3,800 units of product were affected, with one-fifth already returned by retailers.

Prolonged use of the recalled Baby’s Vitamin D3 Liquid could potentially lead to elevated vitamin D levels, resulting in vomiting, loss of appetite, increased thirst, frequent urination, and inability to thrive in infants.

Consumers, distributors, and retailers in possession of the recalled product should discontinue use immediately and return it to the place of purchase for a refund or replacement. The lot number can be found on the back of the box and on the bottle.

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: Nordic Naturals
Brand name: Nordic Naturals
Product recalled: Baby’s Vitamin D3 Liquid
Reason of the recall: Elevated level of Vitamin D3 dosage
FDA Recall date: February 19, 2024

Source: fda.gov
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“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: fda.gov
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