Drug recall: Dr Reddy’s, Sun Pharma, Aurobindo recall these drugs due to this reason

Several major pharmaceutical companies have initiated drug recall due to manufacturing concerns.

May 19, 2024

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Last Updated on October 15, 2024 by The Health Master

Drug recall

The safety of medications is paramount, and recent enforcement actions by the US Food and Drug Administration (USFDA) highlight potential risks associated with certain drugs in the US market by means of drug recall.

Several major pharmaceutical companies, including Dr Reddy’s Laboratories, Sun Pharma, Aurobindo Pharma, and FDC Ltd, have initiated drug recall due to manufacturing concerns.

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Dr. Reddy’s Drug Recall of Medication for Phenylalanine Level Control

Drug: Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg)
Reason for Drug Recall: Classified as “Sub-potent Drug” by the USFDA, meaning it may not contain the intended amount of medication.
Potential Health Risks: Sub-potent medications may not effectively treat the intended condition.
Drug Recall Classification: Class I – The most serious category, indicating a high probability of severe health problems.

Sun Pharma Drug Recall of Antifungal Injection

Drug: Amphotericin B Liposome for Injection
Reason for Drug Recall: “Out of specification for assay,” meaning the drug may not meet quality standards.
Potential Health Risks: The medication’s efficacy may be compromised.
Drug Recall Classification: Class II – Indicates potential for temporary or reversible adverse health effects.

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Aurobindo Pharma Drug Recall of Anti-Anxiety Medication

Drug: Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg)
Reason for Drug Recall: Discoloration (dotted and yellow spots) on tablets, raising concerns about potential contamination or degradation.
Potential Health Risks: The discolored tablets may be ineffective or cause unintended side effects.
Drug Recall Classification: Class II

FDC Ltd Drug Recall of Glaucoma Medication

Drug: Timolol Maleate Ophthalmic Solution
Reason for Drug Recall: Defective Container
Potential Health Risks: Leaky or damaged containers could lead to contamination or inaccurate dosing.
Drug Recall Classification: Class II

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Understanding Drug Recall Classifications

The USFDA categorizes drug recall based on the severity of potential health risks:

Class I: The most serious, involving a high risk of severe health problems or death.
Class II: Products that may cause temporary or reversible adverse health effects, or where the probability of serious harm is low.
Class III: Products unlikely to cause adverse health consequences.

What Consumers Should Do

Check for Recalled Medications: Visit the USFDA website to see if any medications you take are included in a recent drug recall.
Contact Healthcare Provider: Discuss any concerns you have about medications you are taking, especially if they are part of a drug recall.
Follow Drug Recall Instructions: If a medication you use is recalled, follow the manufacturer’s instructions for returning or disposing of the product.
Report Adverse Reactions: If you experience any negative health effects after taking a medication, report them to the USFDA.

Staying Informed about Medication Safety

By staying informed about drug recall and taking appropriate action, consumers can help ensure their own safety and well-being.

Note: This article is for informational purposes only and should not be construed as medical advice. Always consult with a healthcare professional for personalized guidance.

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.