Recall reported for Safety Issues

Dr. Reddy’s Sapropterin Dihydrochloride Powder for Oral Solution - recalled due to decreased potency, USA

3 days ago •source www.fda.gov

Recall notice

Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to … See More

powder discoloration in some packets leading to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints. Sapropterin Dihydrochloride Powder for Oral Solution 100 mg was distributed nationwide to wholesalers/retailers. Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events related to this recall to date.

Reduced efficacy of the product would result in elevated Phenylalaninemia (Phe) levels in patients. Chronically elevated Phe levels in infants and children are likely to cause permanent neurocognitive deficits, including permanent and irreversible intellectual disability, developmental delay, and seizures. Furthermore, elevated Phe levels during pregnancy, especially in early gestation, are associated with microcephaly and congenital heart disease.

The product is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU) and is packaged in individual packets, 30 per carton. The affected Sapropterin Dihydrochloride Powder for Oral Solution 100mg lots include the following:

- Product Name: Javygtor™ (Sapropterin) Dihydrochloride) Powder for Oral Solution 100 mg, Lot Number: T2202812; T2204053; T2300975; T2300976; T2304356, Expiration date: 07/2025; 10/2025; 02/2026; 02/2026; 08/2026, NDC Number: 43598-097-30; 43598-097-30; 43598-097-30; 43598-097-30; 43598-097-30

- Product Name: Sapropterin Dihydrochloride Powder for Oral Solution 100 mg, Lot Number: T2200352, Expiration date: 12/2024, NDC Number: 43598-477-30

Dr. Reddy’s Laboratories Inc. is notifying its distributors and customers by recall notification letters and is arranging for returns of all recalled products. Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should contact their physician before stopping use of the product. Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should return it to their 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: Dr. Reddy’s Laboratories Inc
Brand name: Dr. Reddy’s
Product recalled: Sapropterin Dihydrochloride Powder for Oral Solution 100 mg
Reason of the recall: Decreased Potency
FDA Recall date: April 23, 2024

Source: www.fda.gov

#recall #drugs #us

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Schwinnng Herbal Dietary Supplement - recalled due to contamination with Nortadalafil, USA

3 days ago •source www.fda.gov

Recall notice

STOP CLOPEZ CORP is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has found the Schwinnng products to contain Nortadalafil. Nortadalafil is an active drug ingredient known for the treatment of male erectile dysfunction. The presence of Nortadalafil in Schwinnng capsules makes … See More

it an unapproved new drug for which the safety and efficacy have not been established and, therefore subject to recall. The product was distributed Worldwide via Amazon at www.amazon.com. To date, no adverse events have been reported.

The Schwinnng products contain Nortadalafil, which 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.

This product is marketed as a dietary supplement for male sexual enhancement and is packaged and coded as follows:

SCHWINNNG Lot 2108 EXP 10/2024

STOP CLOPEZ CORP is notifying its customers by this press announcement of this recall release and is arranging for a return of all recalled products. Consumers that have a Schwinnng product that is being recalled should stop using and destroy / return if desired to STOP CLOPEZ CORP. 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Link to FDA Advisory

If you are experiencing symptoms after eating this product 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 attention.

Company name: STOP CLOPEZ CORP
Brand name: Schwinnng
Product recalled: Herbal Dietary Supplement
Reason of the recall: Product is tainted with Nortadalafil
FDA Recall date: April 23, 2024

Source: www.fda.gov

#recall #drugs #us

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Nutrena Country Feeds Meat bird 22% Crumble (RV) - recalled due to non-inclusion of vitamin D, Bryson City, North Carolina, USA

1 week ago •source www.fda.gov

Recall notice

Cargill’s animal nutrition business is conducting a voluntary recall of Nutrena® Country Feeds® Meat bird 22% Crumble (RV) due to non-inclusion of Vitamin D. The affected products were manufactured and sold in the eastern United States and are being recalled from retail outlets in the Alabama, Georgia, … See More

#petfood #cargill #recall #brysoncity #northcarolina #us

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ADM Animal Nutrition Chicken, Swine and Rabbit Feed Products Update - recalled due elevated levels of minerals, USA

2 weeks ago •source www.fda.gov

Recall notice

ADM Animal Nutrition, a division of ADM (NYSE: ADM), is expanding the recall announced on March, 30, 2024, to include the following additional products due to elevated levels of magnesium, sodium, calcium and/or phosphorus: Pen Pals® Chicken Starter-Grower (Product Nos.70009AAA46 and 70009AAA44); Pen Pals Egg Maker Complete … See More

#recall #petfood #us

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Tejocote Dietary Supplements - recalled because it contains toxic yellow oleander, USA

2 weeks ago •source www.fda.gov

Recall notice

Global Mix, Inc. of New York, is recalling tejocote products to include the following brands: Eva Nutrition, Science of Alpha, Niwali, NWL Nutra. The recalled products are labeled as tejocote root but are toxic yellow oleander. The recalled products were distributed in the following states: AL, AK, … See More

CA, CO, CT, DE, FL, GA, HI, ID, IL, IA, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NM, NC, NY, NJ, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, and WY through website. The recalled products were also sold via the below websites via courier direct delivery and mail order. Etsy, amazon, eva-nutrition, tejocotemexican, niwali, scienceofalpha. The recalling firm has not received any reported of illness.

Recalled Products include the following bearing below information. Product codes and expiration dates can be found on the bottom of the packaging.

Product Name: Eva Nutrition MexicanTejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: Science of Alpha Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: NWL Nutra Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: Niwali Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025

Per the safety alert update on 3/12/24, "The FDA continues to receive adverse event reports related to the products identified in this Safety Alert."

The recall was the result of a routine sampling program by the company which revealed that the finished products contained the yellow oleander. The company has ceased the production and distribution of the product as the company continues their investigation as to what caused the problem. Further the company is conducting comprehensive quality control and monitoring process.

Customers who have purchased these products should stop using them immediately and return them to the point of purchase for a full refund.

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.

If you are experiencing symptoms after eating this product 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 attention.

Company name: Global Mix, Inc.
Brand name: Eva Nutrition, Science of Alpha, Niwali, NWL Nutra
Product recalled: Tejocote Dietary Supplements
Reason of the recall: Product contains toxic yellow oleander.
FDA Recall date: April 10, 2024

Source: www.fda.gov

#recall #us

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Medline and Centurion Convenience kits - recalled due to lack of sterility, USA

2 weeks ago •source www.fda.gov

Recall notice

In direct response to the Nurse Assist, LLC voluntary product recall initiated on November 6, 2023, for saline and sterile water medical products, Medline Industries, LP initiated a nationwide recall on November 15, 2023, for its Medline and Centurion branded convenience kits containing Nurse Assist 0.9% Sodium … See More

Chloride Irrigation USP and Sterile Water for Irrigation USP. The Nurse Assist recall was issued due to the potential for a lack of sterility, which could result in non-sterile products. Medline Industries, LP has received one adverse event associated with product manufactured by Nurse Assist.

Water-based medical products that are non-sterile and potentially contaminated could cause serious or life-threatening infections, including bloodstream, urinary tract, open wound/soft tissue, and respiratory 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 exposure to contaminated water-based medical products.

The recall affects Medline and Centurion convenience kits that may be used at home by patients, caregivers, and home health providers, as well as convenience kits that may be used in medical settings for surgery or other medical procedures. Recalled kits include, but are not limited to, wound care kits, tracheostomy kits and catheter kits. A detailed list of recalled Medline and Centurion convenience kits, as well as an example of product labeling, can be found in the link below.

Consumers who have recalled product should stop using the product and contact Medline immediately.

Medline Industries, LP notified its direct distributors and consumers of the Nurse Assist recall by First Class Mail and email on 11/16/23, upon receipt of initial recall notification from Nurse Assist. Customers who received the recalled product were given instructions to quarantine all affected products immediately and provide Medline with a response regarding the affected quantity on hand. Upon confirmation of the affected quantity, Medline provided customers with over-labels to place on the affected inventory, with instructions for staff to remove the affected component before using the kit. The recall notification also instructed distributors and those who resold or transferred affected product to another company or individuals to notify their customers of this 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: Medline Industries, LP
Brand name: Medline and Centurion
Product recalled: Convenience kits
Reason of the recall: The potential for a lack of sterility
FDA Recall date: April 08, 2024

Source: www.fda.gov

#recall #medicaldevices #us

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Tide, Gain, Ace, and Ariel Detergent Packets recalled due to Risk of Serious Injury, USA

2 weeks ago •source www.cpsc.gov

Recall notice

Procter & Gamble has issued a recall for 8.2 million bags of Tide, Gain, Ace, and Ariel laundry detergent pods due to a risk of serious injury. The packaging of these products can split open, posing a risk if the contents are ingested or come into contact … See More

with skin or eyes. The issue with the packaging was discovered after the company received four reports of children in the United States accessing the liquid laundry packets, three of which reported ingestion during the time period that the recalled lots were sold. However, it is not known if these laundry packets came from the recalled bags. No confirmed cases directly relating to this packaging defect have been reported.

The recall involves Tide Pods, Gain Flings, Ace Pods, and Ariel Pods liquid laundry detergent packets packaged in flexible film bags. These products were manufactured between September 2023 and February 2024. The recall applies to bags containing 12 to 39 laundry detergent packets, with a variety of scents and types:
- Gain Flings Original
- Gain Flings Moonlight Breeze Scent
- Gain Flings Blissful Breeze Scent
- Gain Flings Spring Daydream Scent
- Gain Flings Plus Ultra Oxi
- Gain Flings Plus Odor Defense
- Tide Pods Original
- Tide Pods Spring Meadow Scent
- Tide Pods Light
- Tide Simply Pods Plus Oxi Boost
- Tide Pods Clean Breeze Scent
- Tide Pods Free & Gentle
- Tide Pods Oxi
- Tide Pods Ultra Oxi
- Ace Pods Clean Breeze
- Ace Pods Spring Meadow
- Ariel Pods Alpine Breeze

The products were sold At: Big Lots, CVS, Family Dollar, Home Depot, Sam’s Club, Target, Walmart, and other major stores nationwide and online at Amazon.com and other websites from September 2023 through present for between $5 (one 12 ct. bag) and $30 (four 39 ct. bags in a box). The total number of recalled units is approximately 8.2 million, with an additional 56,741 sold in Canada.

Please do not use this product if you have it at home and return it to the store where it was purchased for a full refund and a free replacement child-resistant bag to store the product.

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: www.cpsc.gov

#recall #us

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Aruba Aloe Hand Sanitizer Gel and Alcoholada Gel - recalled because they contain Methanol, USA

3 weeks ago •source www.fda.gov

Recall notice

Aruba Aloe Balm N.V. is voluntarily recalling 40 lots of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel to the consumer level. The products have been found to contain alcohol denatured with methanol. Products were distributed between 5/1/2021 and 10/27/2023 and sold in … See More

the US online only via the Aruba Aloe Balm N.V. website. To date, Aruba Aloe Balm N.V. has not received any reports of adverse events related to these products.

Aruba Aloe Hand Sanitizer Gel is used as a sanitizer to help reduce bacteria that potentially can cause disease and is packaged in 12 fl oz (355 mL) dark green plastic bottles with white label reading in part “ARUBA ALOE Hand Sanitizer GEL 80% Alcohol Made in Aruba World’s Finest Aloe”, with barcode 0 82252 03300 5.

Aruba Aloe Alcoholada Gel is used for temporary relief of pain and itching associated with minor burns, sunburn, insect bites, or minor skin irritations and is packaged in two sizes: 2.2 fl oz (65 mL) plastic bottles with barcode 0 82252 34030 1 and 8.5 fl oz (251 mL) plastic bottles with barcode 0 82252 03120 9. The plastic bottles are transparent with a label reading in part “Alcoholada Gel Pain Relieving Gel 0.5% Lidocaine Hydrochloride”.

The affected Aruba Aloe Hand Sanitizer GEL product lots (filled in 12, 2.2, and 8.5 fl. oz bottles bottles) can be viewed in the link below.

Aruba Aloe Balm N.V. has notified all customers that bought these products by email and has offered a discount coupon for a next purchase. Consumers that have products which are being recalled should stop using and discard the product.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache blurred vision, coma, seizures, permanent blindness, permanent damage to the central nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk for methanol poisoning.

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: Aruba Aloe Balm N.V.
Brand name: Aruba Aloe
Product recalled: Hand Sanitizer Gel and Alcoholada Gel
Reason of the recall: Product contains methanol
FDA Recall date: April 05, 2024

Source: www.fda.gov

#recall #us

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Honeywell Non-Sterile Eyewash Cartridge - recalled due to Non-compliance, USA

3 weeks ago •source www.fda.gov

Recall notice

Honeywell Safety Products USA, Inc. is voluntarily recalling Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station. This recall is being conducted at the industrial consumer level. Honeywell’s supplier of the Fendall 2000 Non-Sterile Eyewash Cartridge has been found to be non-compliant with current good … See More

manufacturing practice (cGMP) requirements. To date, Honeywell Safety Products USA, Inc. has not received any reports of adverse events related to this recall.

The Fendall 2000 Non-Sterile Eyewash Cartridge is used for flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination. Product is contained in a 25-liter Ethylene-vinyl acetate (EVA) bag that is designed for use with the Fendall 2000 Eyewash Station. Only the Fendall 2000 refill cartridges are subject to this review, no other eyewash products. The saline eyewash solution contains purified water, benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate diabasic, and sodium phosphate monobasic. It is not marketed as sterile.

- Fendall 2000 Non-Sterile Eyewash Cartridge. Manufacturer’s Product Number/ Catalog Number: 32-002050-0000. Manufacturing Dates: 11-Oct- 2021 through 21-Jun-2023. Expiration Date: 11-Oct-2023 through 21-Jun-2025. Region: USA. Quantity: 6,954.

- Fendall 2000 Non-Sterile Eyewash Cartridge. Manufacturer’s Product Number/ Catalog Number: 32-002050-0000. Manufacturing Dates: 11-Oct- 2021 through 21-Jun-2023. Expiration Date: 11-Oct-2023 through 21-Jun-2025. Canada. Quantity: 3,651

Honeywell Safety Products USA, Inc. is notifying its distributors and customers by email, telephone or certified mail and is requesting anyone with product in its inventory to destroy or dispose of all units subject to the recall. Customers / distributors / retailers that have Fendall 2000 Non-Sterile Eyewash Cartridges should stop selling, shipping, and using the product immediately and destroy or dispose of it. Customers with questions regarding this recall can contact Honeywell Safety Products USA, Inc. by telephone.

Risk Statement: Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range of ocular infections such bacterial keratitis or endophthalmitis. Immunocompromised individuals, those sustaining ocular injuries that damage the corneal epithelium, and those sustaining penetrating ocular injuries are at higher risk of potential infection.

Company name: Honeywell Safety Products USA
Brand name: Fendall 2000
Product recalled: Non-Sterile Eyewash Cartridge
Reason of the recall: Non-compliance with current good manufacturing practice (cGMP) requirements.
FDA Recall date: April 05, 2024

Source: www.fda.gov

#recall #drugs #us

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ForeverMen Natural Energy Boost - recalled due to undeclared allergens, USA

3 weeks ago •source www.fda.gov

Recall notice

FAonline INC, is voluntarily recalling all lots within expiry of the ForeverMen capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the … See More

#recall #allergicreaction #dietarysupplements #us #allergen

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Recall

Dr. Reddy’s Sapropterin Dihydrochloride Powder for Oral Solution - recalled due to decreased potency, USA

Schwinnng Herbal Dietary Supplement - recalled due to contamination with Nortadalafil, USA

Nutrena Country Feeds Meat bird 22% Crumble (RV) - recalled due to non-inclusion of vitamin D, Bryson City, North Carolina, USA

ADM Animal Nutrition Chicken, Swine and Rabbit Feed Products Update - recalled due elevated levels of minerals, USA

Tejocote Dietary Supplements - recalled because it contains toxic yellow oleander, USA

Medline and Centurion Convenience kits - recalled due to lack of sterility, USA

Tide, Gain, Ace, and Ariel Detergent Packets recalled due to Risk of Serious Injury, USA

Aruba Aloe Hand Sanitizer Gel and Alcoholada Gel - recalled because they contain Methanol, USA

Honeywell Non-Sterile Eyewash Cartridge - recalled due to Non-compliance, USA

ForeverMen Natural Energy Boost - recalled due to undeclared allergens, USA

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