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2160 West Miles Avenue, Hayden, Idaho, United States

Updated:

Recent Interesting Reports

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
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#recall #drugs #us

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
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#recall #us

C
I received a package containing SUBGENIX BIORIBOSE. MY OLD CARD WAS BILLED FOR THIS I didn't order it. Subsequently my card was cancelled. I'm waiting for my new one. I'm 20lbs under weight, the last thing I need is a weight loss supplement.

#unorderedpackage #delivery #virginiabeach #virginia #us

T
I don't know what happened, All I know is I received an email from my credit union last week asking me if I ordered anything online, and I told them no, and then this week I get this package. The bubble envelope says Fullfillment House PO Box 5708 Tampa FL 33675

#unorderedpackage #delivery #uspostalservice #tampa #florida #us

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