Novartis Recalls Millions Of Samples Due To Packaging Glitch

Here is a headache no drugmaker wants to endure. Last July, Novartis began recalling a few million bottles of samples of different medicines that were distributed to physicians, because routine testing determined that a chemical used in shrink wrap packaging was found to leech into some tablets. The incident appears to be an unusual instance in which samples given to doctors have been yanked.

The voluntary recall amounted to 127 lots of samples for three blood pressure treatments - Exforge, Tekturna and Diovan – as well as the Lescol cholesterol pill and the Stalevo Parkinson’s drug, although a Novartis spokeswoman was unable to say many bottles were involved in the recall, although The Wall Street Journal reported about 5.3 million bottles were involved. The disclosure was made in an FDA enforcement report posted on the agency web site on 19th  Dec 2013.
 

In explaining the mishap, the spokeswoman wrote that the sample sleeves were made by a third-party manufacturer and have since been discontinued using that ink component. The drugmaker maintains that an “extensive medical safety assessment” was conducted and shared with the FDA, which concluded there were no patient safety risks.
 

However, Novartis (NVS) is uncertain how many patients may have received the samples. Novartis “informed the physicians who received the samples with a letter explaining the voluntary recall and worked with them to manage the sample return process. We don't track how healthcare providers use the physician samples provided to them,” the spokeswoman writes us. If you look at the enforcement report, the FDA classified the recalls as a Class 2 action, which the agency defines as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
 

The drugs, themselves, were made at Novartis facilities in Suffern, New York; Wehr, Germany, and East Hanover, New Jersey, where the drugmaker maintains US headquarters. The third-party manufacturer was not identified.

Source: http://www.pharmalive.com/novartis-recalls-millions-of-samples-due-to-packaging-glitch