Xgen Pharms' Generic Pentamidine Isethionate Receives Approval in the U.S.
Enforcement Report - Week of August 16, 2017
Enforcement Report - Week of April 12, 2017
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.