Dr. Reddy's Laboratories Continues Nationwide Recall of Levetiracetam Injection Due to Mislabeling

Dr. Reddy's Laboratories has continued its voluntary nationwide recall of Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL, due to mislabeling. The recall affects Lot ABD807, which was distributed in the U.S. between August 14 and September 5, 2018. The mislabeling could lead to adverse reactions such as somnolence, agitation, and respiratory depression if the product is administered incorrectly. Despite the potential risks, no adverse events have been reported to date. The recall was initiated with the knowledge of the U.S. FDA, and distributors have been notified to return the affected products.

 

Sources: BSE, Business Standard, FDA, Times of India