Basak, S. "Sun Pharma Recalls 400,000 Bottles of Drugs in U.S., FDA Says," Bloomberg News, May 8, 2014.
India's largest drug manufacturer Sun Pharmaceutical Industries Ltd., is recalling nearly 400,000 bottles of its generic form of the anti-depressant Effexor (Venlafaxine) and the antihistamine Cetirizine because the pills fail to dissolve properly.
 Basak, S. "Sun Pharma Recalls 400,000 Bottles of Drugs in U.S., FDA Says," Bloomberg News, May 8, 2014.
Teva Pharmaceutical has issued a voluntary recall of certain lots of the antidepressant Duloxetine Delayed-Release Capsules (generic Cymbalta) due to a customer complaints of capsule breakage. The recall affects 1,050,266 bottles of drugs. FDA has classified the recall as Class II. Teva is also voluntarily recalling 257,832 cylinders of inhaled asthma drug QVAR®, manufactured for Teva by 3M in California. The drug is being recalled because it failed testing for impurity and degradation specifications. FDA has classified the recall as Class III. Read more about Recalls.
 FDA, Enforcement Report - Week of April 9, 2014.
Pfizer Inc. is voluntarily recalling one lot of 30-count Effexor XR® (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules and one lot of 90-count Greenstone LLC-branded Venlafaxine HCl 150 mg extended-release capsules.
This action is being taken because a pharmacist reported that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn® (dofetilide) 0.25mg in addition to the Effexor XR capsules. Although Pfizer has not received any other such reports, these three lots are being voluntarily recalled as a precaution because they were packaged on the same line.
Effexor XR is a prescription antidepressant indicated for the treatment of major depressive disorder, general anxiety disorder, social anxiety disorder, and panic disorder with or without agoraphobia. Tikosyn is a Class III (cardiac action potential duration prolonging) antiarrhythmic drug. It is used to treat irregular heartbeats (such as atrial fibrillation (AF) and atrial flutter (AFL)) and to maintain normal sinus rhythm (normal heartbeat) in patients with AF or AFL of greater than one week duration who have been converted to normal sinus rhythm.
Tikosyn can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, which can lead to death. If an Effexor XR/Venlafaxine HCl patient thinks they may have mistakenly ingested a Tikosyn capsule, they should immediately contact their physician or hospital. Patients should also watch for signs of abnormal heartbeat, and inform their physician or hospital if they feel faint, become dizzy or have a fast heartbeat.
 FDA Recall -- Firm Press Release, "Pfizer Initiates Nationwide Voluntary Recall of Two Lots of Pfizer's Effexor XR® 150 Mg Extended-Release Capsules and One Lot of Greenstone's Venlafaxine HCl 150 Mg Extended-Release Capsules Due to the Possible Presence of Tikosyn® Capsules," March 6, 2014.
A new class action alleges Forest Pharmaceuticals covered up the potential risks of the antidepressants Lexapro and Celexa. Plaintiffs argue that the manufacturer concealed findings that the drugs were not effective in children. Lexapro has also been the subject of litigation alleging that the drug causes birth defects such as heart defects, craniosynostosis, oral clefts, and club foot.
Johnson & Johnson (J&J) and its subsidiary Janssen Pharmaceuticals have agreed to pay more than $2.2 billion to resolve criminal and civil allegations that the company marketed two powerful antipsychotic drugs, Risperdal and Invega, and one drug used to treat heart failure, Natrecor, for unapproved "off-label" uses. All three of the drugs were aggressively marketed by the company to control erratic behavior in vulnerable patients including children, seniors, and the mentally disabled. The settlement is the third largest settlement with a drug maker in U.S. history.
In 1993, Risperdal was approved for treatment of schizoprenia, but J&J soon began promoting the drug for "off-label" uses that helped the drug become its #1 selling product by 2005 with sales over $3.5 billion. In the plea agreement, Janssen admitted to promoting Risperdal as way to control behavior in seniors with dementia -- a use which is now explicitly prohibited on the drug's warning label because it can increase the risk of stroke and death in elderly patients.
In 1999 FDA had warned Janssen that marketing to Risperdal as a safe and effective for the elderly would be "misleading," but over the years the company persisted in targeting nursing homes, nursing home pharmacists, and doctors who treated the elderly. All the while, the company downplayed the drug's risks, including diabetes, weight gain, and risk of stroke. Meanwhile the company also increased marketing of Risperdal to child psychiatrists as a treatment for common childhood disorders, such as attention deficit disorder and autism.
The off-label uses of Risperdal, Invega, and Natrecor caused wasteful spending by federal and state health programs like the Department of Veterans' Affairs, Medicare, and Medicaid. As part of the settlement, the company agreed to pay $1.72 billion in civil payments to federal and state governments as well as $485 million in criminal fines and forfeited profits.
 Perrone, M. et al. "Johnson & Johnson To Pay $2.4 Billion To Resolve Drug Marketing Allegations," Huff Post (11/04/2013; 01/23/2014).
Early in January Eli Lilly & Co. entered into an agreement with the U.S. attorney's office of the Eastern District of Pennsylvania and 30 states to pay $1.4 billion to settle charges that it illegally marketed its anti-psychotic drug Zyprexa for off-label uses. Zyprexa is one of the biggest-selling drugs in the world, with billions of dollars in sales. The settlement is believed to be the largest health care fraud settlement in history. The marketing campaign known as "Viva Zyprexa" promoted the anti-psychotic drug for unapproved uses such as the treatment of depression, anxiety, irritability, disrupted sleep, nausea and gambling addiction. Eli Lilly also provided payments and benefits to physicians and health care professions that prescribed Zyprexa. As a result of the campaign, Zyprexa was prescribed for children, adolescents, and dementia patients for uses that were unapproved and ran afoul of Medicaid reimbursement programs.
Late in January the company also pled guilty to a misdemeanor for promoting Zyprexa to the elderly as a treatment for Alzheimer's even though the drug isn't approved by the FDA for such uses. As part of the guilty plea, Lilly must also pay a fine and forfeiture of $615 million, $438 million to the federal government, and $362 million to the settling states.
Thousands of plaintiffs have also brought individual suits against Eli Lilly, many accusing the company of failing to provide adequate warnings that the drug may cause weight gain and diabetes.
In addition Lilly has been sued by insurance companies and other organizations for breaking marketing laws and overcharging for the drugs.
 Daly, E. "Lilly Officially Pleads Guilty In Zyprexa Debacle," Law360 (January 30, 2009).
 USA v. Eli Lilly & Co., Case No. 2:09-cr-00020,United States District Court for the Eastern District of Pennsylvania.