Aurobindo Recalls 1.5 Million Bags For Issues of Sterility Assurance
Auromedics Pharma, a Princeton, New Jersey-based subsidiary of Aurobindo Pharma, a Hyderabad, India-headquartered generics and active pharmaceutical ingredients manufacturer, has voluntarily initiated a recall in the US of 1.5 million bags of assorted antibiotic and anti-seizure injectable medicines due to lack of sterility assurance.
A recall report issued by the US Food and Drug Administration says there was a confirmed customer report of leaking bags and mold found between the outer bag and the overwrap. The recall was initiated March 27, 2018, according to the FDA.
The company is recalling over 390,000 bags of linezolid injection (600 mg per 300 mL (2 mg/mL), an antibiotic, over 660,000 bags of various formulations of levofloxacin, an antibiotic, and over 280,000 bags of various formulations of levetiracetam, an anti-seizure drug.
The FDA has classified the recall as Class II. A Class II recall is a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.