Alembic and Aurobindo issue US drug recalls, citing quality and production issues
21 Aug 2023
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Source: FiercePharma
Alembic and Aurobindo Pharma posted voluntary recalls for drugs used to treat eye infections and high blood pressure, respectively.
Alembic and Aurobindo Pharma, the U.S. unit of India’s Aurobindo, issued voluntary recalls of products because of quality issues and manufacturing deficiencies, respectively.
Alembic recalled 82,400 bottles of the bacterial eye infection treatment tobramycin, according to an advisory posted on the FDA website. The nationwide recall kicked off July 27.
In its notice, the company said the action was taken due to “failed impurities/degradation specifications.”
As for Aurobindo, the company recalled a total of 96 bottles of rufinamide tablets for treating seizure disorders. The company's recall covers 48 bottles of 400-mg dosages and 48 bottles of 200-mg dosages.
In both cases, the recalls were initiated due to the products being distributed throughout the U.S. without being approved.
The two recalls were issued by the company July 21.
The companies aren't strangers to manufacturing-related recalls and shortfalls.
Last October, Aurobindo pulled two batches of quinapril and hydrochlorothiazide tablets due to high nitrosamine levels. Quinapril and hydrochlorothiazide are a fixed-combination tablet used to lower blood pressure.
That same month, Alembic’s site in Gujarat, India, was slapped with a Form 483 from the FDA. The document listed four observations in the wake of a 10-day inspection. That facility produces oncology injectables.
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