Last Updated on March 19, 2025 by The Health Master
Drug Recall
Two major Indian pharma companies, Sun Pharmaceutical Industries and Zydus Pharmaceuticals, have started drug recall of their products in the United States.
As per the recent report from the US Food and Drug Administration (USFDA), these drug recall have been initiated due to some issues in manufacturing and quality control, which raises concerns about the quality of the drugs manufactured by these companies.
Drug recall Sun Pharma:
Morphine Sulfate: Dissolution Issues
Sun Pharmaceutical Industries, Inc., has started a nationwide Class II drug recall of 9,840 bottles of Morphine Sulfate extended-release tablets.
The main reason mentioned by the USFDA is “Failed Dissolution Specifications.”
This indicates that the tablets may not be dissolving as intended, potentially affecting the drug’s absorption and efficacy in patients.
This is a very serious issue, as proper dissolution is very important to ensure the proper drug delivery and therapeutic outcomes.
Details of this Drug Recall:
- Name of drug: Morphine Sulfate extended-release tablets
- Quantity: 9,840 bottles
- Reason: Failed Dissolution Specifications
- Class: Drug Recall Class II
- Date of Drug Recall: February 6, 2025
Drug Recall by Zydus Pharmaceuticals:
Nelarabine Injection: Impurity Concerns Arise
Zydus Pharmaceuticals (USA) Inc. has started a drug recall of the product Nelarabine Injection, which is used in the treatment of cancer.
The main reason for this drug recall is “Failed Impurities / Degradation Specifications.”
This reason points out that the vials may contain a high level of degraded components or impurities, which can affect the efficacy, effectiveness and safety of the drug.
Details of this Drug Recall:
Name of drug: Nelarabine Injection (250mg/50mL, 5mg/mL)
Quantity: 36,978 vials (in first drug recall) and 1,893 vials (in second drug recall)
Reason: Failed Impurities/Degradation Specifications
Class: Drug Recall II
Date of First Drug Recall: February 2025
Date of Second Drug Recall: February 13, 2025
Let’s understand Class II Drug Recall:
The USFDA classifies drug recalls based on the seriousness of health risks.
A Class II drug recall highlights a condition where the use or exposure of a defective product may cause temporary or medically reversible adverse health issues.
Q. What is meant by Class II drug recall?
A. A Class II drug recall highlights a condition where the use or exposure of a defective product may cause temporary or medically reversible adverse health issues.
Q. Why have Sun Pharma and Zydus recalled their products?
A. Sun Pharma is recalling Morphine Sulfate tablets due to failed dissolution specifications, while Zydus is recalling Nelarabine Injection due to failed impurities/degradation specifications.
Q. What are dissolution specifications for pharma products?
A. Dissolution specifications are tests that measure the rate and extent to which a drug dissolves from a dosage form.
Q. What are the impurity/degradation specifications?
A. These specifications define the limits of acceptable levels of impurities or degraded products within a drug product.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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