Source: Osha.gov | Receipt Date: 2020-10-23
Report by
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74 855 Country Club Drive, Palm Desert, California, United States
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Source: Osha.gov | Receipt Date: 2020-10-23
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Dr. Reddy’s Sapropterin Dihydrochloride Powder for Oral Solution - recalled due to decreased potency, USA
3 days ago •source www.fda.gov
Recall notice
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
A package, Trail, Oregon, USA
2 weeks ago •reported by user-jnvf3475
JCEX
Rosewood P is the company
2800 n. Franklin rd
Indianapolis Indiana
46219
Manilla envelope approx 3"×7"
..Necklace ( aerosols breathlace(rose gold))..written on outside.
Ref.# BB30209047968-209****
They have our POB, Street address and telephone #
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
Elevated levels of sodium can cause increased water consumption, reduced feed efficiency, egg production, and growth rate and can be fatal in chickens. Elevated levels of calcium and/or phosphorus can cause reduced feed intake and feed conversion in swine, and elevated levels of magnesium and sodium can cause loose stools, reduced growth rate, and weakness in rabbits.
In case your animals experience harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: ADM Animal Nutrition
Brand name: Pen Pals, MaxLean, ShowTec, MoorMan's
Product recalled: Chicken, Swine and Rabbit Feed Products
Reason of the recall: Specific lots may contain elevated levels of magnesium, sodium, calcium and/or phosphorus
FDA Recall date: April 11, 2024
Source: www.fda.gov
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