Unapproved Medication Pulled from Shelves
A federal injunction has stopped Maryland based Neilgen Pharmaceuticals from selling more than 50 unapproved medications. Medications sold by Neilgen which also operates under the name, Unigen were mainly prescription cough and cold products. The U.S. Food and Drug Administration filed a complaint in Baltimore's U.S. District Court claiming the drugs were improperly manufactured, carried inadequate directions for use and were not FDA-approved.
Neilgen and its parent company, Advent Pharmaceuticals agreed to the injunction without admitting or denying the allegations. By agreeing to the injunction the company must destroy their existing drug supply and is prohibited them from manufacturing any new drugs without FDA approval. Outside counsel must also be hired to advise the company on complying with U.S. manufacturing standards. Any violation of the injunction will result in fines of over $1 million per year.
It is unclear on where the drugs were sold but an ongoing investigation by the Maryland U.S. attorney's office is hoping to discover where and when the drugs were sold.
The following cough and cold products were manufactured by the companies:
- 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
- Chlorpheniramine Maleate 12 mg/Pseudoephedrine HCl 120 mg LA Tablets
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