The U.S. Food and Drug Administration announced that it had received a permanent injunction stopping a Westminster, Maryland based pharmaceuticals company and its Windsor, New Jersey-based parent company from manufacturing and distributing 50 unapproved drug products, which primarily include prescription cough and cold products.
FDA noted that Neilgen Pharmaceuticals Inc. and its parent company, Advent Pharmaceuticals Inc., who are contract manufacturers and distributors of more than 25 different unapproved drug products each, are barred from manufacturing and distributing any unapproved, adulterated or misbranded drugs. Neilgen also does business as Unigen Pharmaceuticals Inc.
The unapproved drugs manufactured by Unigen and/or Advent include, RE All 12 Suspension, BP Allergy Junior Suspension, PE Tann 20 mg/CP Tann 4 mg Suspension, BP New Allergy DM Suspension, D-Tann CT Tablets, B-Vex D Suspension, Histex SR, and Chlorpheniramine Maleate 12 mg/Pseudoephedrine HCl 120 mg LA Tablets.
FDA also stated that company employees Bharat Patel and Pragna Patel also signed a consent decree in the U.S. District Court of Maryland on April 9, 2009, to destroy their existing drug supply, and prohibiting them from commercially manufacturing and distributing any new drugs without its approval.
The regulatory stated that the unapproved drugs manufactured by these two companies have not undergone its drug approval process, and urged consumers to discontinue using them and pharmacists to discontinue dispensing these products.
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