A roundup of manufacturing news from Aurobindo. Highlights below.

* Aurobindo Recalls Two Lots of Quinapril and Hydrochlorothiazide Tablets Due to Nitrosamine Impurity

Aurobindo Recalls Two Lots of Quinapril and Hydrochlorothiazide Tablets Due to Nitrosamine Impurity
Aurobindo Pharma, a Hyderabad, India-based bio/pharmaceutical manufacturing company, has initiated a voluntary recall of two lots of quinapril and hydrochlorothiazide tablets (USP 20 mg/ 12.5 mg) to the consumer level in the US due to the presence of a nitrosamine drug-substance-related impurity, N-nitroso-quinapril, above the proposed interim limit.

Quinapril and hydrochlorothiazide tablets are a fixed-combination product that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide. This product is indicated for treating hypertension.

Aurobindo began shipping of the subject batches to customers nationwide in May 2021.

This is a second recent voluntary recall of quinapril and hydrochlorothiazide tablets due to a nitrosoamine impurity. Earlier this year (March 2022), Pfizer also voluntarily recalled quinapril and hydrochlorothiazide products due to the presence of the nitrosamine impurity, N-nitroso-quinapril, above the acceptable daily intake level. It recalled six lots of Accuretic (quinapril HCl/hydrochlorothiazide) tablets, distributed by Pfizer as well as two authorized generics distributed by Greenstone: one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/ hydrochlorothiazide tablets.

The issue of nitrosamine impurities in certain generic active pharmaceutical ingredients (APIs) first emerged in 2018 when the US Food and Drug Administration and the European Medicines Agency initiated investigations of nitrosamine impurities in certain “sartan”-containing APIs used in anti-hypertensive and cardiovascular drugs, such as valsartan candesartan, irbesartan, losartan, and olmesartan. They later broadened those investigations into prescription and over-the-counter forms of ranitidine, a H2 (histamine-2) blocker used to decrease the amount of acid created by the stomach, and later metformin extended-release products, used to treat Type II diabetes. As part of their investigations, the regulatory agencies issued guidelines for testing of products to detect nitrosamine impurities, acceptable daily intake levels, and risk evaluation and risk assessment.

Source: US Food and Drug Administration