Two subsidiaries of Indian pharmaceutical companies Aurobindo Pharma and Zydus Lifesciences voluntarily took two drugs off the market in late September.
Aurobindo recalled 1,626 vials of Triamcinolone Acetonide Injectable Suspension, an important generic corticosteroid treatment used to take care of numerous ailments, from arthritis to intestinal disorders. The product was recalled by Eugia US LLC, a 100 percent owned subsidiary of Aurobindo Pharma Ltd, and was initiated on September 28. The product will be recalled voluntarily by the company nationwide in the U.S.
The product was manufactured at Aurobindo’s labs in India. It was recalled due to “a piece of glass identified in a vial,” the FDA said.
Then there is Zydus. They recalled 7,248 bottles of Oxybutynin Chloride Extended-Release Tablets, used to treat urinary conditions. The voluntary recall was initiated on September 21, with tablets of 100 grams and 500 grams recalled because the pill did not dissolve properly.
The product was manufactured at Cadila Healthcare in India and is distributed by a wholly owned subsidiary of Zydus Lifesciences, known as Zydus Pharmaceuticals USA. Many of the big generic drug brands people see when driving through New Jersey and elsewhere are often either research & development facilities, or just used as marketing, sales and distribution centers for imported drugs.
In January, Aurobindo’s Eugia US recalled Acyclovir Sodium Injections, often used to treat sexually transmitted infections. Some 45,000 vials sold in the U.S. were found by the lab to be contaminated with particulate matter. The Class II recall took that drug off the market this year.
Dozens of drugs are voluntarily recalled nationwide, every day. According to the FDA, some 6,261 biologics, generic drugs and drug delivery products were recalled this year so far, versus 5,862 in 2022. Most recalls are voluntarily and not done due to FDA inspectors finding faulty products. It is up to the manufacturer to notify the supply chain, and the FDA, who in turn notifies the public. The majority of recalls are considered Class II, though there are hundreds (around 250 this year) of Class I recalls annually and these are the most dangerous products for patients.
The FDA has better access, however, to domestic labs and can visit them unannounced. This makes it easier to pressure manufacturers to make high quality, safe products. Although the FDA does inspect labs in India, it does so less often and is more dependent on the labs recalling faulty products.
Numerous Indian labs, including Aurobindo labs, have been on the receiving end of Warning Letters during the sporadic FDA visits in the last year. Aurobindo’s labs were inspected twice this year, once in May and again in July. In July, the FDA reported that it found “buildings were not clean or in a sanitary condition” and that the lab lacked “written procedures for the cleaning and maintenance of equipment.”
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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