The company said that the recall was being initiated because of failures in environmental monitoring of the facility where the drugs are made, leading to drug quality concerns.
Astral SteriTech, a contract drug manufacturer owned by Centrient Pharmaceuticals out of The Netherlands, has voluntarily recalled numerous antibiotics it makes for U.S. importers due to an equipment problem at its lab in the city of Vadodara in Gujarat state, India.
The company said that the recall was being initiated because of failures in environmental monitoring of the facility where the drugs are made, leading to drug quality concerns. The environment in the lab is important to drug making as it can affect the sterility of the products being made there.
The affected products were sterile antibiotic powders used for injection that were manufactured in India between May 2020 and April 2023.
Astral sells the recalled medication to Utah-based Civica Rx, Meitheal Pharmaceuticals of Chicago, Piramal Critical Care and Xelia Pharmaceuticals of Denmark, which also distributes pharmaceuticals throughout the U.S. from its facilities in Illinois, Ohio and North Carolina.
The recall was first noted by the California Board of Pharmacy. The recall was not listed on the FDA’s data dashboard for Centrient or Astral SteriTech as of the morning hours of Friday, May 19.
According to the FDA, Astral SteriTech’s lab in Gujarat was last inspected on April 3, 2018. It received a clean record from its inspection.
A Centrient facility in India was inspected by the FDA was July 1, 2022 at a lab in Punjab, India. The lab received an Official Action Indication classification after the visit, which means the FDA found practices that were not in line with standards required by American producers of pharmaceuticals. A Warning Letter was sent to the lab on December 7, 2022 because of that inspection.
Astral has not received reports of adverse events relating to this issue, the California Board of Pharmacy said. Intravenous or intramuscular administration of a product for which sterility cannot be assured could result in serious systemic infections. The Board said that further sales or use of these products “should cease immediately.”
A May 9th hearing by the Senate Committee on Finance said that drug shortages in the United States were often caused by multinational pharmaceutical companies, like Centrient, contracting its lab work from overseas players in order to shift tax burdens. They argued that existing tax schemes made it less favorable to produce pharmaceuticals in the United States, including generic drugs, long considered a commodity item in the pharma business.
On May 19, Israeli based generics giant, Teva Pharmaceuticals, said it would be cutting back on production of generic drugs due to low profitability.
These cutbacks, coupled with dubious offshore labs that go uninspected for years, often loading the U.S. market with drugs that lack efficacy, or can be dangerous, are leading to new sets of problems for America’s drug supply.
The New York Times said in an article dated May 17 that drug shortages were “at an all time high.” The article laid a lot of the blame on intermediaries in the drug sales pipeline that eat into the already thin profit margins of domestic labs, making it even less attractive to produce drugs locally.
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We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.
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