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

RTTNews | 222 дней спустя
Dr. Reddy's Labs Recalls Levetiracetam In Sodium Chloride Injection

(RTTNews) - Dr. Reddy's Laboratories Ltd. is recalling select Levetiracetam in 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.

The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

Both Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL and Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg/100 mL are indicated for adjunct therapy in adults with select seizure types when oral administration is temporarily not feasible.

When administered the mislabeled product, the patient could receive double the dose of intravenous levetiracetam than intended as the infusion bag is labelled as 500 mg/100 mL but actually contains 1,000 mg/100 mL dose. Such patients are likely to experience adverse events, leading to immediate and serious side effects. These include hypersensitivity reactions, liver injury, hematological toxicity, somnolence, fatigue, dizziness, coordination difficulties, agitation, aggression, depressed level of consciousness, respiratory depression, and coma.

The FDA noted that patients receiving high doses of levetiracetam by rapid intravenous infusion for the treatment of status epilepticus would be most at risk for severe adverse events.

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

The recall involves Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, packaged in single-dose infusion bags with an aluminum overwrap, 10 single-dose bags packed in a carton.

The mislabelled bags come with NDC numbers 43598-635-52 and 43598-636-52, with Lot Number A1540076 and Expiration Date of 08/2026. The carton holds NDC number 43598-636-10. The batch was distributed nationwide between November 4, 2024, and November 6, 2024, to wholesalers.

Dr. Reddy's is notifying its distributors and customers to arrange for return of any recalled product. Wholesalers, distributors, hospitals, and pharmacies with an existing inventory of the impacted lot are asked to stop use and distribution and quarantine the product immediately for return/replacement.

Dr. Reddy's last year had called back six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level, due to powder discoloration in some packets leading to decreased potency.

For More Such Health News, visit rttnews.com

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

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

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.
RTTNews | 546 дней спустя
Malaysia Bourse May Give Up Support At 1,600 Points

Malaysia Bourse May Give Up Support At 1,600 Points

The Malaysia stock market has finished lower in two of three trading days since the end of the two-day winning streak in which it had picked up less than a point. The Kuala Lumpur Composite Index now sits just above the 1,600-point plateau and it's likely to extend its losses on Thursday.
RTTNews | 3 минут назад
Losses May Accelerate For Japan Stock Market

Losses May Accelerate For Japan Stock Market

The Japanese stock market on Wednesday ended the two-day winning streak in which it had surged more than 1,730 points or 3.4 percent. The Nikkei 225 now sits just above the 49,300-point plateau and it may take further damage on Thursday.
RTTNews | 18 минут назад
South Korea Shares Overdue For Profit Taking

South Korea Shares Overdue For Profit Taking

The South Korea stock market has tracked higher in six straight sessions, accelerating more than 320 points or 8.6 percent in that span. Now at another fresh record closing high, the KOSPI rests just above the 3,880-point plateau although investors figure to lock in gains on Thursday.
RTTNews | 33 минут назад
South Korea Rate Decision On Tap For Thursday

South Korea Rate Decision On Tap For Thursday

The Bank of Korea will wrap up its monetary policy meeting and then announce its decision on interest rates, highlighting a modest day for Asia-Pacific economic activity. The BoK is expected to keep its benchmark lending rate steady at 2.50 percent.
RTTNews | 1ч 33мин назад
Swiss Market Ends Slightly Weak

Swiss Market Ends Slightly Weak

The Switzerland market edged down marginally on Wednesday after a cautious session, as investors looked for directional clues.
RTTNews | 5ч 22мин назад
Major European Markets Close Weak; UK Market Outperforms

Major European Markets Close Weak; UK Market Outperforms

The major European markets closed mostly lower on Wednesday as investors reacted to earnings updates and other corporate news, in addition to following the developments on the trade front and digesting geopolitical news.
RTTNews | 5ч 56мин назад