The 300mg products are packaged in 100-count bottles, NDC 16714-662-01, with ‘D’ imprinted on a yellow cap and ‘03’ on the yellow body with black edible ink. The affected lot, GESB14011-A, was distributed through Northstar label to pharmacies in the US.
The company said empty capsules could result in missed doses, with possible adverse consequences ranging from no effect to life-threatening seizures.
So far it has received four complaints about empty capsules, but no adverse event reports.
Aurobindo, based in India, manufactures therapies for neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporin indications for global markets.