After Spice, Indian Medicines Being Recalled From US Over Manufacturing Issues


Mohul Ghosh

Mohul Ghosh

May 20, 2024


Indian pharmaceutical companies, including Dr Reddy’s Laboratories, Sun Pharma, and Aurobindo Pharma, have initiated product recalls in the US market due to manufacturing issues. According to the latest Enforcement Report by the US Food and Drug Administration (USFDA), these recalls stem from concerns about product quality and compliance with safety standards.

After Spice, Indian Medicines Being Recalled From US Over Manufacturing Issues

Dr Reddy’s Laboratories has recalled nearly 20,000 cartons of Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg), which is used to control blood phenylalanine levels in adults and children. The Princeton, New Jersey-based arm of Dr Reddy’s initiated this recall because the drug was found to be sub-potent. This Class I recall, which was started on April 8, 2023, involves defective products that can cause serious health problems.

Sun Pharma’s Amphotericin B Liposome Recall

Sun Pharma is also recalling 11,016 vials of Amphotericin B Liposome for Injection, a medication used to treat fungal infections, from the US market. This recall was initiated on April 19, 2023, and is classified as a Class II recall due to the product being out of specification for assay. Class II recalls are issued when a violative product may cause temporary or medically reversible adverse health consequences, with a remote probability of serious health issues.

Aurobindo Pharma’s Clorazepate Dipotassium Recall

Similarly, Aurobindo Pharma has recalled 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg), which are used to treat anxiety. This recall was initiated on April 24, 2023, because the tablets were found to have discoloration, with dotted and yellow spots. This recall is also classified as Class II by the USFDA.

FDC Ltd’s Timolol Maleate Ophthalmic Solution Recall

Another pharmaceutical company, FDC Ltd, based in Aurangabad, Maharashtra, has recalled 3,82,104 units of Timolol Maleate Ophthalmic Solution, which is used to treat glaucoma. The recall was due to defective containers and was also classified as Class II.

Impact on the US Generic Drug Market

The US generic drug market, valued at approximately USD 115.2 billion in 2019, is the largest market for pharmaceutical products. These recalls highlight the ongoing challenges faced by pharmaceutical companies in maintaining stringent quality standards in the highly regulated US market. Ensuring compliance with the USFDA’s safety and quality requirements is crucial for these companies to sustain their market presence and protect consumer health.


Mohul Ghosh
Mohul Ghosh
  • 980 Posts

Subscribe Now!

Get latest news and views related to startups, tech and business

You Might Also Like

Business
Dec. 8, 2022

Beat The Burden Of Medical Inflation With A Health Insurance

As disease rates rise and medical technology develops, treatment costs climb. It’s essential to understand that medical costs are not exclusively associated with hospitals. The cost of prescription drugs, diagnostic procedures, ambulance and operating room fees, consultations with doctors, and other costs are also constantly increasing. All of them could put a big strain on […]

Business
Dec. 8, 2022

3 Biggest Changes Of iOS 16.2 Update That Every iPhone User Should Know!

In its latest update Apple said that it is preparing for the iOS 16.2 update for iPhones across the world. Notably, like the previous release, there are a couple of changes coming for the iPhones.  iOS 16.2 Update Release Date So far, Apple has not announced a release date for iOS 16.2 update. Reportedly, the […]

Business
Dec. 8, 2022

300 Microsoft Employees Create Employee Union, First Time Ever: This Is How Microsoft Reacted

Around 300 workers at Microsoft Corp.’s ZeniMax Studios have commenced the process of forming a union which is said to be the first at the software giant in the US.  Here, Microsoft Corp.’s ZeniMax Studios known for popular video games including Skyrim and Fallout. Forming Union In Microsoft Corp Moreover, the quality assurance employees at […]

Business
Dec. 7, 2022

India Beats China In Air Travel Safety: Ranking Jumps From 102 To 48 In Global Aviation Safety

India’s air safety protocols and executions have improved drastically over the years, as validated by the findings of a specialized agency of the United Nations, the International Civil Aviation Organization or ICAO. The UN watchdog has upgraded India’s ranking in terms of aviation safety to the 48th position, jumping past the rankings of countries like […]

Recent Posts

Related Videos

   

Subscribe Now!

Get latest news and views related to startups, tech and business

who's online