Citing manufacturing 'deviations,' Macleods recalls drugs to treat high blood pressure, schizophrenia

Macleods Pharmaceuticals issued voluntary recalls for two products used to treat high blood pressure and schizophrenia due to deviations from standard manufacturing protocols, according to FDA reports.

The New Jersey-based arm of the Indian drugmaker issued a nationwide recall on Feb. 15 for 3,672 bottles of amlodipine and olmesartan medoxomil tablets, which are used to treat high blood pressure. 

Additionally, the company issued a recall on Feb. 16 for one lot of 10 mg, 30-count bottles of olanzapine, which is used to treat schizophrenia. That recall also cited manufacturing "deviations” as the cause of the action.

Both were class II recalls covering situations in which using or being exposed to the products may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Both products were manufactured by India-based Macleods at its Baddi (Himachal Pradesh) production plant and were distributed in the U.S. through Macleods Pharma USA. Specific details of the manufacturing issues weren’t disclosed in a notification posted on the FDA website. 

Macleods was among the wave of companies in 2019 that issued recalls for the high blood pressure treatment losartan that contained impurities traced back to APIs manufactured by Hetero Labs Limited.