Ibuprofen Lysine Injection is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective. The product is packaged in three 2 mL Single-Dose vials per carton, and bears the NDC 39822-1030-2. The affected Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL) is from lot PLND1613, Expiration Date 02/2018. The product can be identified by X-Gen logo, and by the NDC number on the individual vial (39822-1030-1). The product was distributed nationwide to wholesalers and distributors for further distribution to hospitals and retail customers.
After a case last year levied by the Australian Federal Court over “misleading conduct” concerning the marketing of its branded painkiller Nurofen, Reckitt Benckiser has now had its fine increased from $1.7 million to $6 million following an appeal from the Australian Competition and Consumer Commission (ACCC).
Reckitt Benckiser has been hit with two major scandals over the weekend as the British consumer healthcare and drug company is forced to apologize for misleading customers and selling products that killed or injured people.nnIn its first penalty, the company has been fined A$1.7 million ($1.3 million) in Australia for misleading customers over its Nurofen (ibuprofen) tablets by marketing the meds as being able to target specific pains--something it cannot actually do.
Exela Pharma’s Generic Ibuprofen Lysine approved in US a NSAID