FDA Obtains Permanent Injunction against Two Drug Manufacturers
The Food and Drug Administration recently announced that it had obtained a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals Inc. (Advent), of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated, or misbranded drugs.
Both Neilgen, which does business as Unigen Pharmaceuticals Inc. (Unigen), and Advent are contract manufacturers and distributors of more than 25 different unapproved drug products each. The unapproved drug products primarily include prescription cough and cold products. These include, but are not limited to:
- 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.
The unapproved drugs manufactured by these companies have not undergone FDA's drug approval process, so their safety and effectiveness have not been established and the FDA has not reviewed the adequacy and accuracy of the directions for use and warnings on the labeling.
Consumers in possession of any of these products should discontinue using them and discuss FDA-approved treatments with their health care professional. Pharmacists should discontinue dispensing these products.
The defendants signed a consent decree that orders them to destroy their existing drug supply, and prohibits them from commercially manufacturing and distributing any new drugs without FDA's approval.