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Subpotent Fluoride Tabs Results in $4.7 Million Whistleblower Award

United States Justice Department officials and regulators have settled Medicaid fraud charges against Vintage Pharmaceuticals (doing business as Qualitest Pharmaceuticals), its parent Endo Pharmaceuticals and several other affiliates. All of the charges relate to fluoride supplements sold by...

Emcure: Big Pharma’s Offshoring cGMP Tsunami?

Pharma manufacturing cGMP has lately become an unbelievable drumbeat of Enforcement Reports and FDA and EMA Import Bans, even repeatedly, at several generic manufacturers. 
But is non-compliance convulsing so much in the ground beneath our industry that we now have the “Big Pharma...

Disappointment with FDA’s Open Records Policy

Rarely do we express disappointment with the FDA. They do an extraordinary job keeping us safe. We never waivered in our support for the FDA in 2007 when Congress (and the public) blamed the agency for the deaths of 149 Americans who received adulterated heparin.
Americans receive billions of...

Epinephrine and Atropine Shortages, Recalls and Potential Bad Products

Available only with a physician’s prescription, epinephrine is used for the emergency treatment of life-threatening allergic reactions (anaphylaxis). It is available either in injectable form (solution in a vial) or already packaged in an injector. Common U.S. brand names include Adrenaclick,...

Big Pharma, The White House and Congress

The U.S. Food and Drug Administration is charged with insuring that the drugs we take are safe and come with appropriate warnings. A recent trial shed light on how big pharma sometimes attempts to tamper with regulators.
Documents revealed in a recent trial suggest that McNeil Consumer...


India's Wockhardt Continues Drug Recalls after USFDA Concerns

As of August 2015, India’s generic pharma manufacturer Wockhardt Ltd. has ordered a total of 35 recalls of approximately 20 different drugs as part of a remediation plan in response to concerns arising from a 2013 inspection by the United States Food and Drug Administration (USFDA). Recalls...

California Oncologist Settles Counterfeit Drug Allegations

California Oncologist Settles Counterfeit Drug Allegations

The U.S. Department of Justice announced that it has settled allegations against a Stockton, California oncologist for dispensing counterfeit and unapproved chemo drugs to his patients. Under the terms of the deal, Dr. Neelesh Bangalore will pay the government $736,000. As part of the deal, Dr. Bangalore was not required to admit any wrongdoing.

The Justice Department accused Dr. Bangalore of dispensing Altuzan, a chemotherapy drug, to his patients. The drug was allegedly imported into the U.S. by Warwick Healthcare Solutions Inc. (Richards Pharma). Warwick is not licensed by the FDA.

Unapproved AND Counterfeit Altuzan with no API

Worse than the licensing problems, Altuzan is not FDA approved. Although apparently approved for use in Turkey, it is not distributed in the U.S. The FDA claims it tested the drug dispensed by Bangalore and determined it was counterfeit and contained no API....



Looming Drug Potency Issues for American-Bound Pharmaceuticals?

Looming Drug Potency Issues for American-Bound Pharmaceuticals?India’s leader in US-bound generic pharmaceuticals, Dr. Reddy’s Laboratories, is now facing several large product recalls due to significant deviations in potency of active pharmaceutical ingredients.  FDA issued an Enforcement Report on May 6, 2015 announcing the recall of...