The pre-printed text content on the infusion bag indicates the product information as Levetiracetam in .75% sodium chloride injection 1000mg/100ml; however, the label on the external foil pouch has the correct product information: Levetiracetam .54% sodium chloride injection 1500mg/100ml.
Levetiracetam injection is an antiepileptic drug indicated for adjunct therapy in adults when oral administration is temporarily not feasible.
No adverse events have been reported in relation to this recall. Patients who may have been administered the mislabeled product could experience adverse reactions such as somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma related to over dosage.
The batch was distributed in the US between August and September 2018. Dr. Reddy’s notified distributors to arrange for return of any recalled product.
It has not be disclosed which company site manufactured the mislabeled products.
Dr. Reddy’s voluntarily recalled 236,000 bottles of statins in July 2018, after impurities were found in the products.
All of the recalled medicines were produced at Dr. Reddy’s facility in Srikakulam, India. That facility received a Form 483 with 13 observations from the US Food and Drug Administration (FDA) in May 2018.