Dr. Reddy's Recalls Sapropterin Dihydrochloride Powder For Oral Solution

RTTNews | 552天前

(RTTNews) - Dr. Reddy's Laboratories Ltd. is recalling six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level.

According to the U.S. Food and Drug Administration, the recall was due to powder discoloration in some packets leading to decreased potency.

The product is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia or HPA due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU).

Reduced efficacy of the product would result in elevated Phenylalaninemia or Phe levels in patients. Chronically elevated Phe levels in infants and children may cause permanent neurocognitive deficits, and elevated Phe levels during pregnancy, especially in early gestation, are associated with microcephaly and congenital heart disease.

The issue was discovered during an accelerated stability test in addition to customer complaints.

However, Dr. Reddy's has not received any reports of adverse events related to the recall so far.

The impacted drug is packaged in individual packets, 30 per carton. The affected drugs include Javygtor Powder for Oral Solution 100 mg with lot mumbers T2202812, T2204053, T2300975, T2300976, and T2304356; as well as Sapropterin Dihydrochloride Powder for Oral Solution 100 mg with lot code T2200352.

The product was distributed nationwide to wholesalers/retailers.

Dr. Reddy's is notifying its distributors and customers and is arranging for returns of all recalled products.

For More Such Health News, visit rttnews.com

Dr. Reddy's Labs Recalls Levetiracetam In Sodium Chloride Injection

Dr. Reddy's Laboratories Ltd. is recalling Levetiracetam in 0.75% Sodium Chloride Injection in the United States citing mislabeling of infusion bag, according to the U.S. Food and Drug Administration. The recall involves one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level.

RTTNews | 228天前

U.S. Consumer Confidence Edges Modestly Lower In October

Consumer confidence in the U.S. saw a modest deterioration in the month of October, according to a report released by the Conference Board on Tuesday. The Conference Board said its consumer confidence index dipped to 94.6 in October from an upwardly revised 95.6 in September.

RTTNews | 59分钟前

PayPal Lifts FY25 Outlook Above Market, Teams With OpenAI; Stock Up

Shares of PayPal Holdings, Inc. were gaining around 15 percent in the pre-market activity on the Nasdaq, after the company issued earnings forecast for its fourth quarter expecting year-over-year growth, and raised fiscal 2025 outlook above the market estimates. The payment technology major also initiated quarterly cash dividend after reporting higher third-quarter results above market.

RTTNews | 2小时15分钟前

Falling Commodity Prices Likely To Weigh On Canadian Market At Open

Canadian market is likely to open on a negative note Tuesday morning, weighed down by falling crude oil and gold prices. The mood is likely to remain cautious ahead of the monetary policy announcements from the Bank of Canada and the Federal Reserve on Wednesday.

RTTNews | 2小时40分钟前

German GfK Consumer Sentiment To Continue Falling On Weak Income Expectations

German consumer confidence is likely to continue its downward trend in November on weaker income expectations, monthly survey data published jointly by NIQ/GfK and the Nuremberg Institute for Market Decisions showed Tuesday. The forward-looking consumer climate indicator fell unexpectedly to -24.1 in November from revised -22.5 in October. The score was expected to improve to -22.0.

RTTNews | 3小时31分钟前

UPS Sees Q4 Revenues Above Street As Q3 Beats Market, Despite A Fall; Stock Gains

Shares of United Parcel Service Inc. were gaining around 9 percent in the pre-market activity on Tuesday after the logistics major issued fourth-quarter outlook for revenues above market estimates after the third-quarter adjusted earnings and top line beat the Street. On a reported basis, third-quarter earnings were down mainly as revenues were hit by weak results in U.S. Domestic and Supply Chain

RTTNews | 3小时48分钟前

FTSE 100 Flat; HSBC Holdings, Airtel Africa Rise After Results

U.K.'s FTSE 100 index is moving in a very narrow range on Tuesday with stocks turning in a mixed performance as investors react to earnings updates, and look ahead to crucial central bank meetings, and continue to follow the developments on the trade front for further direction.

RTTNews | 4小时14分钟前

CAC 40 Down Slightly; Earnings In Focus

French stocks are turning in a mixed performance on Tuesday with investors reacting to some quarterly earnings announcements, and awaiting the upcoming meeting of U.S. President Donald Trump and Chinese President Xi Jinping, and monetary policy decisions from central banks, including the European Central Bank, the Federal Reserve and the Bank of Japan.

RTTNews | 4小时47分钟前

EURUSD	1.16572	GBPUSD	1.32755	AUDUSD	0.65769
USDJPY	152.025	USDCAD	1.39501	USDCHF	0.79339