Aurobindo Pharma arm recalling 48,000 vials of Gentamicin Injection in U.S.
Eugia US LLC, a step down subsidiary of Hyderabad-headquartered generic drugmaker Aurobindo Pharma, is recalling 48,000 vials of Gentamicin Injection paediatric doses from the U.S.
The Gentamicin Injection, USP, (paediatric), 20 mg per 2 mL, 2 mL Single-Dose Vial are manufactured in India, the latest enforcement report of the U.S Food and Drug Administration showed.
The injections are being recalled as a result of failed stability specifications - out of specification results for the colour absorbance test during 12 month sample analysis, the regulator said.
It is a voluntary recall and initiated by the company on May 29. Gentamicin is an antibiotic and used to treat bacterial infections.
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Eugia US LLC, a step down subsidiary of Hyderabad-headquartered generic drugmaker Aurobindo Pharma, is recalling 48,000 vials of Gentamicin Injection paediatric doses from the U.S. The Gentamicin Injection, USP, (paediatric), 20 mg per 2 mL, 2 mL Single-Dose Vial are manufactured in India, the latest enforcement report of the U.S Food and Drug Administration showed. The injections are being recalled as a result of failed stability specifications - out of specification results for the colour absorbance test during 12 month sample analysis, the regulator said. It is a voluntary recall and initiated by the company on May 29. Gentamicin is an antibiotic and used to treat bacterial infections.
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