Mumbai-based Wockhardt Ltd is recalling 109,744 bottles of its generic version of AstraZeneca's hypertension drug Toprol XL in the U.S.
The recall was initiated following failed dissolution tests, according to the U.s. FDA.
A tablet that does not disintegrate in the required period of time will fail dissolution tests. Active absorption of oral dosage forms depends on adequate release of the API from the product, so dissolution plays a pivotal role in this.
According to Bloomberg, the FDA is planning an extensive study of generic Toprol XL. Complaints against the drug cite a lack of effectiveness as well as troublesome side effects.
Last year, Wockhardt had two Indian facilities placed on the FDA's import-alert list.
Read the Bloomberg press release