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

RTTNews | 491日前
Dr. Reddy's Recalls Sapropterin Dihydrochloride Powder For Oral Solution

(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

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

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 | 167日前
European Shares Seen Higher At Open

European Shares Seen Higher At Open

European stocks are seen opening broadly higher on Thursday even as Nvidia's disappointing sales forecast raised concerns about the AI spending boom.
RTTNews | 34分前
Sensex Nifty Decline On Tariff Worries

Sensex Nifty Decline On Tariff Worries

Indian shares opened on a sluggish note on Thursday after U.S. President Donald Trump's 50 percent tariffs on Indian goods came into effect, impacting trade worth billions of dollars and risking Washington-New Delhi ties.
RTTNews | 1時27分前
European Economic News Preview: Eurozone Economic Sentiment Data Due

European Economic News Preview: Eurozone Economic Sentiment Data Due

Economic confidence and monetary aggregates from the euro area and flash GDP from Switzerland are the top economic news due on Thursday. At 3.00 am ET, the State Secretariat for Economic Affairs is slated to release Swiss GDP data for the second quarter. The economy is expected to grow 0.1 percent sequentially after rising 0.5 percent in the first quarter.
RTTNews | 1時28分前
Australian Market Trims Early Losses In Mid-market

Australian Market Trims Early Losses In Mid-market

The Australian market is trimming early losses in mid-market moves on Thursday, giving up some of the gains in the previous session, despite the broadly positive cues from Wall Street overnight. The benchmark S&P/ASX 200 is falling to near the 8,950 level, with weakness in iron ore miners, energy and technology stocks partially offset by gains in financial stocks.
RTTNews | 2時54分前
Asian Markets Trade Mostly Higher

Asian Markets Trade Mostly Higher

Asian stock markets are mostly higher on Thursday, following the broadly positive cues from Wall Street overnight, as traders remain optimistic the US Fed will cut interest rates at their next meeting in September. They also remain cautious ahead of the release of key US economic data later in the week, including second quarter GDP and the Fed's preferred readings on consumer price inflation.
RTTNews | 3時9分前
Swiss Market Settles Modestly Higher

Swiss Market Settles Modestly Higher

The Switzerland market closed modestly higher on Wednesday after staying firm right through the day's session, thanks to fairly strong buying at several counters. The benchmark SMI closed up by 46.23 points or 0.38% at 12,207.12. The index moved between 12,166.23 and 12,226.36 during the session.
RTTNews | 3時51分前