April 10, 2009
FDA bars two companies from manufacturing and distributing unapproved drugsThe FDA has announced that it has obtained a permanent injunction barring Neilgen Pharmaceuticals, which does business as Unigen Pharmaceuticals, and its parent company, Advent Pharmaceuticals, from manufacturing and distributing any unapproved, adulterated, or misbranded drugs. The list of unapproved drugs from these companies consists of more than 50 products, primarily prescription cough and cold products, including RE All 12 Suspension, BP Allergy Junior Suspension, PE Tann 20mg/CP Tann 4mg Suspension, BP New Allergy DM Suspension, D-Tann CT Tablets, B-Vex D Suspension, Histex SR, and clorpheniramine maleate 12mg/pseudoephedrine HCl 120mg LA tablets.
Pharmacists should discontinue dispensing these products. Patients who have any of these products in their possession should stop using them immediately and consult their healthcare professional.
For more information visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149564.htm.