Last Updated on October 2, 2024 by The Health Master
Drug recall
Drug recall: In a recent development, the US arm of prominent Indian pharmaceutical giant, Sun Pharmaceutical Industries Inc., has voluntarily recalled a batch of Bupropion Hydrochloride Extended-Release Tablets, a medication used in the treatment of major depressive disorder.
This drug recall, affecting 144 bottles, was prompted by the identification of ‘failed dissolution specifications’, as reported by the US Food and Drug Administration (USFDA).
The drug recall Process
Initiation and Scope of the Recall
On October 4, Sun Pharmaceutical Industries Inc. undertook the recall, swiftly addressing the issue across the entirety of the United States.
The recall, classified as a Class-III recall by the USFDA, pertains to situations where the use or exposure to the product is deemed unlikely to cause adverse health consequences.
Reasoning behind the Recall
The central factor behind this voluntary recall was the detection of ‘failed dissolution specifications’.
This technical term refers to a deviation from the established criteria for the medication’s solubility in a fluid. In simpler terms, the medication did not dissolve as expected, necessitating the recall.
Manufacturing Information
The affected product, Bupropion Hydrochloride Extended-Release Tablets, USP (SR), is primarily utilized for the treatment of major depressive disorder.
The tablets in question were manufactured at Sun Pharmaceutical Industries Limited’s facility located on the Halol-Baroda Highway in Gujarat, India.
Market Impact and Company Response
Impact on Sun Pharma
Sun Pharma, a stalwart in the pharmaceutical industry, has noted that its generic sales experienced a setback due to an import alert at its Halol facility and disruptions in supply from Mohali.
This development, as highlighted in a report by brokerage firm Nuvama, has impacted the company’s overall sales performance.
Awaiting Company’s Statement
Despite attempts to contact Sun Pharma for a statement regarding the recall, there has been no response thus far.
It is anticipated that the company will address the matter in due course, shedding light on further steps or insights pertaining to the recall.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Drug recall: This Nasal Spray recalled due to Microbial Contamination
Drug recall: 7,248 bottles of Oxybutynin Chloride tablets recalled
Drug recall: These injections recalled due to Glass Particulate Matter
Drug recall: Sun Pharma, Aurobindo recall these drugs due to this reason
Drug recall: Ibrexafungerp tablets recalled due to cross contamination
Drug Recall: Sucralfate Oral Suspension recalled due to this reason
Pharmaceutical Quality: Key Amendments in Revised Schedule M
Drug recall: This Nasal Spray recalled due to Microbial Contamination
Fake drug manufacturing factory busted: Dehradun
Reactor blasts in Pharmaceutical Company: Hyderabad
USFDA issues Form 483 with 9 observation to Panacea: Baddi
Govt Job: For the post of Assistant Controller Drugs under Drugs & Food Control
Drug recall: 7,248 bottles of Oxybutynin Chloride tablets recalled
Major Bust: Illegal Alprazolam Factories Unearthed in Pune
Crackdown on Illegal Drug Factory in Ambala Cantt: FDA Haryana Takes Swift Action
Jan Vishwas Act: Transforming Penalties for Drug Advertising Offenses
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
