$11 million in unapproved drugs seized in New Jersey


Ready to take down illegal suppositories at a moment’s notice

U.S. Marshals seized more than $11 million worth of unapproved drugs marketed by Ascend Laboratories of Montvale, N.J. and distributed by Masters Pharmaceuticals of Cincinnati.

Ascend Laboratories is a subsidiary of Alkem Laboratories, one of the top seven pharmaceutical companies in India. Alkem is a vertically integrated organization with 15 manufacturing plants located throughout India, of which four are U.S. Food and Drug Administration approved…

At the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Ohio, the U.S. Marshals seized:

— Pramoxine-HC Otic Drops, intended to treat ear infections caused by microbes and to control itching.

— Hydrocortisone Acetate Suppositories 25 milligrams, intended to treat inflamed hemorrhoids, ulcerative colitis and other inflammatory conditions.

— Urea Cream 39%, Urea Cream 40% and Urea Lotion 40%, intended to treat skin-thickening conditions such as dermatitis and eczema.

None of these products have been proven safe or effective for their intended uses. The FDA recommends that consumers consult a healthcare professional about the continuing use of these drug products”…

The FDA ain’t exactly the most progressive body affecting American healthcare. Still, it’s at least worthwhile to see them following their own regulations about keeping unapproved products off drugstore shelves.

And, then – shall we deal with the creeps who doubtless knew damned well they were importing and distributing unapproved meds, eh?

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