Friday, December 20, 2013

Novartis Recalls About 5.3 Million Bottles of Sample Drugs

Novartis has recalled about 5.3 million bottles of blood-pressure medications and other drugs that were provided as free samples to U.S. physicians' offices, citing potential contamination by a packaging chemical.

The bulk of the voluntary recall, which was initiated in the summer, was for about 4.7 million bottles of hypertension treatments Exforge and a related drug, Exforge HCT, according to information posted online this week by the U.S. Food and Drug Administration. Other drugs included in the recall were blood-pressure treatments Diovan, Tekturna and Tekturna HCT; Lescol XL cholesterol-lowering tablets; and Stalevo for Parkinson's disease.
A Novartis spokeswoman said the company recalled 127 lots of the drugs after routine testing found that trace amounts of an ink component on shrink-wrapped sleeves surrounding the bottles had migrated and affected some tablets contained in some lots of the physician-sample bottles. Each sample bottle contained seven tablets.
The Swiss company said it concluded the issue didn't pose a safety risk to patients, citing a medical assessment, and that it initiated the recall "to ensure compliance with regulatory standards and quality control."
It is unclear how many samples may have reached patients, which Novartis said it doesn't track. The company sent letters to physicians who had received the samples informing them of the recall, and worked with them on returns, the spokeswoman said. The recall didn't include products held by patients or those distributed via wholesalers and pharmacies.
The FDA classified the action as a "Class 2" recall, which the agency reserves for products that may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health problems is remote.
While drug recalls are common, it is relatively rare for a recall to be specific to the free samples provided to doctors.
Novartis and other drug makers routinely provide free promotional samples of prescription drugs to doctors, who in turn provide them to patients. Drug makers hope the free samples will convert to paid prescriptions, and some doctors say the samples help uninsured or under-insured patients afford drugs.
However, critics have said that samples are more likely to go to insured patients, and that the practice boosts overall health-care costs by promoting expensive brand-name drugs over cheaper generic alternatives. Some medical centers have banned doctors from accepting free drug samples.
Novartis said it discontinued use of the ink component for the sample sleeves, which are produced by a third party manufacturer. The ink component is "Darocur 1173," according to the FDA, which is described as a "photocuring agent."
The recalled drugs were manufactured at plants in Suffern, N.Y.; Stein, Switzerland; and Wehr, Germany; and were distributed by Novartis Pharmaceuticals Corp., East Hanover, N.J.
Novartis has grappled with other product recalls in recent years, including over-the-counter medicines such as Excedrin that were manufactured at a plant in Lincoln, Neb., before the company suspended production at the site in late 2011 to address manufacturing-quality problems identified by the FDA.

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