AuroMedics Pharma, a U.S.-based unit of Indian drugmaker Aurobindo, issued a voluntary recall of one lot of the antibiotic polymyxin B following a complaint that a hair was found in a vial.
The recall affects lot number CPB200013 polymyxin B for injection with an expiration date of September 2022, according to the recall notice posted on the FDA’s website. The lot was distributed nationwide in the U.S.
Polymyxin B for injection is a sterile, white lyophilized cake or powder. It's used to prepare sterile solutions for intramuscular, intravenous, intrathecal or ophthalmic use to treat infections of the urinary tract, meninges (membranes that protect the brain and spinal cord) and bloodstream caused by susceptible strains of bacteria.
AuroMedics, which is based in New Jersey, said it notified distributors and is arranging for the return and replacement of the recalled product. The company said it has not received any reports of adverse effects related to the recall.
RELATED: FDA slaps Aurobindo with warning letter on API testing failures, repeated violations
The voluntary recall by AuroMedics comes days after news its parent company, Aurobindo, was hit with a warning letter from the FDA for failing to adequately investigate batch failures of pharmaceutical ingredients and not evaluating the possible effect of changes on the intermediates and APIs manufactured at its facility in Telangana, Hyderabad, India.