Brent Adams & Associates Legal Blog

Ranbaxy Recalls Antibiotics After Color Change Detected

India’s largest producer of prescription drugs, Ranbaxy Laboratories, announced a recall of antibiotic drugs this week. The two lots of antibiotic drugs, which are used to treat ear, nose, and throat infections in children, changed color – a change that sparked the recall. Although the color change does not signal a defect in the drug, and although the drugs were tested for defects after the change was detected, the large pharmaceutical company has decided to go ahead with the drug recall.

The FDA has determined that the antibiotics recall is a class II incident, meaning that there is no serious danger associated with the drug. About 35,000 bottles of the imported antibiotic drug are involved in the voluntary recall. The drug maker does not expect the recall to harm their profits because of the small size of the recall.

Ranbaxy’s manufacturing sites have been under fire by US regulators who say that the factories do not meet United States standards – and 30 different drugs made in India by the company were banned in 2008.