Alembic Pharmaceuticals and Aurobindo Pharma issued voluntary recalls of different products in the US markets because of quality issues and manufacturing deficiencies, according to the US Food and Drug Administration (USFDA).
Aurobindo Pharma, the US unit of Aurobindo, initiated the Class II nationwide (US) recall of rufinamide tablets used for treating seizure disorders on July 21. It recalled a total of 96 bottles in different strengths, including 48 bottles of 400 mg dosage and 48 bottles of 200 mg dosage. The reason for the recall was current good manufacturing practice (cGMP) deviations, the US FDA statement said.
As for the New Jersey-based subsidiary of Alembic Pharmaceuticals, the company kicked off a nationwide Class III recall of 82,400 5ml bottles of Tobramycin Ophthalmic Solution, a bacterial eye infection treating drug, on July 27 due to “failed impurities/degradation specifications.”
In both cases, the recalls were initiated because the products were distributed throughout the US without approval.
Aurobindo also called back two batches of quinapril and hydrochlorothiazide tablets because of high nitrosamine levels in October last year. These are fixed-combination tablets used to lower blood pressure.
Shares of both companies saw a sharp drop in prices on Tuesday. Aurobindo shares hit an intraday low of Rs 828.80, a nearly 2.9% fall from the previous closing price on the National Stock Exchange (NSE), while Alembic saw its stock touch a low of Rs 760, down almost 2%.
At 12:10 pm, shares of Alembic Pharmaceuticals were trading 1.32% lower at Rs 765. The scrip of Aurobindo traded at Rs 832.05, 2.5% less than the last closing price.