Aurobindo Pharma and Glenmark Recall Their Products in the United States
The US health agency has said that drug manufacturers Aurobindo Pharma, Glenmark, and Zydus are recalling medicines in the US market because of production problems. Aurobindo Pharma USA Inc., a division of a Hyderabad-based pharmaceutical company, is recalling more than one lakh bottles of Cinacalcet tablets in various strengths, according to the most recent Enforcement Report from the US Food and Drug Administration (USFDA). Due to "GMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit," the US health authorities announced that the New Jersey-based company was recalling the product.
On November 7 of this year, the business started the Class II recall. The treatment for hyperparathyroidism involves the use of cinacalcet pills. Similarly, approximately 90,000 bottles of Diltiazem Hydrochloride extended-release capsules (various strengths) are being recalled from the US market by Glenmark Pharmaceuticals, a company situated in the US.
Glenmark Pharmaceuticals Inc Recalling Diltiazem Hydrochloride
"cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit" is the reason given by the US health regulator for the recall of the impacted batch of Diltiazem Hydrochloride extended-release capsules manufactured by Glenmark Pharmaceuticals Inc., based in New Jersey.
Extended-release capsules of diltiazem hydrochloride are used to treat hypertension. On November 1st of the current year, the business started the Class II nationwide (US) recall. The USFDA also said that a labelling issue has led to Zydus Pharmaceuticals (USA) Inc. recalling 4,404 boxes of Esomeprazole Magnesium for Delayed-Release Oral Suspension (40 mg). The drug is used to address specific issues with the oesophagus and stomach. On November 14, the business began a nationwide recall of the impacted packets.
What is Class II Recall?
According to the USFDA, a Class II recall is started when there is a remote chance of substantial adverse health effects or when using or being exposed to a product that violates the law may result in short-term or medically reversible negative health effects.
India produces 60,000 distinct generic brands in 60 therapeutic categories, making it the world's largest provider of generic medications, accounting for about 20% of the worldwide supply. Over 200 countries get the nation's manufactured goods, with the US, Western Europe, Japan, and Australia being the top destinations.
Nitin Konde
Must have tools for startups - Recommended by StartupTalky
- Convert Visitors into Leads- SeizeLead
- Manage your business smoothly- Google Workspace
- International Money transfer- XE Money Transfer
