Drug recall: Sun Pharma recalls about 1.10 lakh bottles of Tadalafil in US market

The Mumbai-based drugmaker is recalling the product in 30-count bottles of 5mg and 20 mg strengths.

124
Recall
Picture: Pixabay

Last Updated on November 23, 2021 by The Health Master

New Delhi: Drug major Sun Pharmaceutical Industries is recalling over 1.10 lakh bottles of a generic medication used to treat erectile dysfunction in men in the US market due to a manufacturing error.

The US arm of the domestic pharma major is recalling Tadalafil tablets in the American market, according to the latest enforcement report of the US Food and Drug Administration (USFDA).

The Mumbai-based drugmaker is recalling the product in 30-count bottles of 5mg and 20 mg strengths.

The company is recalling 73,957 bottles of 5 mg strength and 36,786 bottles of 20 mg strength, the US health regulator stated.

An affected lot of the medication was manufactured by the drug maker in India and distributed in the US by Princeton, New Jersey-based Sun Pharmaceutical Industries Inc, it said.

Elaborating on the reasons for the Class II recall, the USFDA said: “An incorrect grade of Crospovidone was used to manufacture the product.”

As per the USFDA, a class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The company initiated the nationwide recall on October 25, 2021.

Earlier this month, Sun Pharma had initiated a recall of 22,752 blister packs of Loratadine-D extended-release tablets, used for the treatment of allergic rhinitis and the common cold, in the US market.

According to USFDA, the drugmaker is recalling the affected lot due to “failed moisture limits.”

The US generic drug market was estimated to be worth around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.

Drug recall: Sun Pharma, Lupin recall products due to these reasons

Drug recall: Cook Medical recalled these Medical Devices

Drug recall: BP medicine recalled due to this reason

Drug recall: Merck recalls Daptomycin for Injection 500mg

Drug recall: Glenmark, Aurobindo recall multiple products

Auro Pharma recalls batches of Drug used to treat severe disease

Lung cancer management in the era of precision medicine

CDSCO panel rejects Synokem Pharma’s application for oral Antidiabetic Drug

PLI schemes for Pharma and Medical Devices to make India secure

Zydus Cadila gets USFDA nod to market generic Cancer drug in…

Govt transfers AYUSH-64 drug technology to 46 Companies

Fake doctor arrested

Eli Lilly files litigation against 20 Indian Pharma Companies

Experts ask Govt to bring list of OTC Drugs

Retired FDA officials are promoting Generic Drugs in innovative ways

Latest Notifications regarding Pharmaceuticals

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news

Enter your email address:

Delivered by FeedBurner