Cadila Healthcare arm recalls hypertension drug in US

Zydus Pharmaceuticals USA Inc has initiated a nationwide voluntary recall of acyclovir and carvedilol tablets in the US for labelling mix-up.

The US arm of the Gujarat-based pharmaceutical company Cadila Healthcare has recalled 3,900 bottles of hypertension drug carvedilol tablets, 6.25 mg, in 500 count bottles, after a report was received of one bottle labelled as acyclovir tablets, 400 mg, actually contained carvedilol tablets 6.25 mg.

The recall is included in a recent US Food and Drug Administration (FDA) Enforcement Report. 

Acyclovir is a prescription antiviral used to treat cold sores, shingles, chickenpox and other herpes infections. Carvedilol is a prescription beta-blocker used to treat high blood pressure and heart failure. 

The recall affects 100-count bottles of 400-mg acyclovir tablets manufactured by Cadila Healthcare with an expiry of November 30, 2020. The bottles were distributed throughout the United States by Zydus Pharmaceuticals.

The company has voluntarily initiated the recall on April 25. On May 7, the FDA designated the recall as Class II, where use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. 

Earlier this month, Zydus recalled 7,668 bottles of carvedilol tablets after "presence of foreign tablets/capsules" was reported.

“Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of carvedilol tablets 3.125mg,” the US FDA said. The recall was classified as Class III in which use of or exposure to a violative product is not likely to cause adverse health consequences.

The ongoing recalls by the Indian pharma companies in the US are happening in the midst of a book published on how generic drugs are poisoning patients. In the book “Bottle of Lies: The Inside Story of Generic Drug Boom” on how generic drugs are manufactured and why they weren't as effective as patented drugs.

The main story in the book revolves around Ranbaxy – its history, people, culture, ambition, rise to fame and the eventual fall with the unprecedented fine by the FDA and the successful litigation by Daiichi for misrepresenting its regulatory issues with the US FDA.

The investigative work takes into account the experiences of FDA inspectors while visiting the Indian manufacturing units and the actions taken by them in regarding their compliance with the good manufacturing practices.

On Monday, brokerage firm India Infoline in a research note said that it has met the officials of Indian Pharmaceutical Alliance to comprehend the industry's response to the allegations in the book. 

“The key takeaway from the meeting was that FDA has engaged with Indian generic manufacturers, via IPA, to help improve various aspects of manufacturing quality. The IPA shared some prepared materials with us, opposing the views presented in the book. Apart from showcasing their commitment to quality through the above-mentioned initiatives, the IPA materials highlight FDA statements supporting generic manufacturers in India and China. In its letter released in Feb-2019, the FDA says that its inspectional footprint is robust, including in India and China. FDA targeting has significantly improved in the past few years, given that the Centre for Drug Evaluation & Research (CDER, part of the FDA) is issuing five times as many Warning Letters in FY18 as it did in FY15. Random sampling of imported products by the FDA has largely met the standards of quality.”

The brokerage argued that despite the book being on the Amazon US bestseller list (new releases) during the past week, the generic industry has a strong advocate in the FDA.

“This will be a firm positive for India Pharma and should help cushion any adverse impact triggering from the issue,” India Infoline said in its note.