Last Updated on November 17, 2024 by The Health Master
Drug recall
Dr. Reddy’s Laboratories and FDC Ltd., two prominent pharmaceutical companies, have initiated drug recall of their generic drugs in the US market due to identified manufacturing issues.
These drug recall, as detailed by the US Food and Drug Administration (USFDA), highlight the stringent quality control standards enforced by the regulatory body.
Dr. Reddy’s Drug Recall of Morphine Sulfate
Dr. Reddy’s Laboratories Inc., a US-based subsidiary of the Indian pharmaceutical giant, is recalling multiple strengths of Morphine Sulfate extended-release tablets.
This drug is widely prescribed for the management of severe and persistent pain.
The drug recall, classified as a Class II nationwide drug recall, was initiated on October 22, 2024.
The affected lots were identified due to “Failed Impurities/Degradation Specification.”
FDC’s Drug Recall of Timolol Maleate Ophthalmic Solution
FDC Ltd., headquartered in Mumbai, India, is recalling Timolol Maleate ophthalmic solution.
This drug is commonly used to treat high pressure inside the eye associated with glaucoma.
The drug recall, also categorized as a Class II drug recall, was initiated on October 29, 2024.
The affected lots were identified due to “Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.”
Understanding Class II Drug Recall
A Class II drug recall is initiated when the use or exposure to a defective product may cause temporary or medically reversible adverse health consequences.
While the risk of serious adverse health effects is considered remote, the USFDA takes such drug recalls seriously to protect public health.
India’s Role in Global Pharmaceutical Supply
India plays a pivotal role in the global pharmaceutical industry, particularly in the manufacturing and supply of generic drugs.
The country supplies approximately 20% of the world’s generic drugs, catering to over 200 countries.
The US, Japan, Australia, and West Europe are among the primary destinations for Indian-manufactured pharmaceuticals.
Key Takeaways
- Dr. Reddy’s and FDC have initiated recalls of their drugs due to manufacturing issues.
- The drug recalls are classified as Class II, indicating a potential risk of temporary or reversible adverse health effects.
- India is a major supplier of generic drug to the global market.
- Regulatory authorities like the USFDA play a crucial role in ensuring the safety and efficacy of drugs.
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Why are these drugs being recalled?
Both Dr. Reddy’s and FDC have identified manufacturing issues that could potentially compromise the quality and safety of the affected products.
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What should patients do if they have these drugs?
Patients who have purchased the recalled drugs should contact their healthcare provider or pharmacist for further guidance. They may be advised to return the unused portion of the drug to the pharmacy or dispose of it safely.
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What steps are being taken to prevent future drug recalls?
Both companies are likely to conduct thorough investigations into the root causes of the manufacturing issues. They may also implement additional quality control measures to prevent similar incidents in the future.
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.
Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
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