Manufacturing problems have led to the recall of the thyroid-hormone replacement therapy Synthroid for the second time in 6 months. This time, however, the responsibility for the return of more than 28,520 bottles of the drug falls on the shoulders of AbbVie ($ABBV), the new company that resulted from the Jan. 1 spinoff from Abbott Laboratories ($ABT) of its branded drug business.
AbbVie spokesman Gregory Miley told The Wall Street Journal that the voluntary recall resulted from a "manufacturing line clearance error." An FDA enforcement report dated Jan. 9 said the product labeled as having "150 mcg tablets actually contained 75 mcg tablets." No adverse events have been recorded, Miley said, and AbbVie has taken steps to fix the problem.
AbbVie is not the first company to suffer from line clearance problems. In fact that was one of the key problems found by the FDA that led Novartis ($NVS) to close its over-the-counter plant in Lincoln, NE, a year ago for significant upgrades. In that case, the FDA said there were reports of Excedrin Migraine tablets also containing Excedrin caplets and regular-strength aspirin in an Excedrin Migraine geltabs carton. There were also chipped, crumbled and discolored products reported in some containers. Novartis was also making opioids for Endo Health Solutions ($ENDP), and the FDA in one case said, "28 assorted tablets were found in troughs for Oxycodone ER, Percocet and others."
While AbbVie's line clearance problems do not rival the issues at the Novartis plant, it also is not the first time the company has had manufacturing-related problems with Synthroid. In July, Abbott recalled 136,500 bottles of the drug after some bottles had a "thin wall defect on the bottom which may potentially impact the stability of the tablets," an FDA enforcement report said. The company said at the time that most of the product had not been shipped.
Abbott in 2012 reported $461 million in sales of Synthroid worldwide in the first 9 months of the year, The Wall Street Journal reports. AbbVie, which officially became its own entity this month, sells Synthroid in the U.S. and Abbott sells it outside of the U.S.
- read the Wall Street Journal story (sub. req.)