Last Updated on August 4, 2025 by The Health Master
Drug recall
Sun Pharmaceuticals, a major global pharmaceutical company, started a drug recall of their Lisdexamfetamine Dimesylate capsules across the United States.
This important development highlights the strict quality control standards within the pharmaceutical industry and the regular vigilance required to ensure patient safety.
The drug recall, impacting a drug commonly used for Attention Deficit Hyperactivity Disorder (ADHD), stems from a failure to meet “Dissolution Specifications.”
Understanding the drug recall:
Mumbai-based Sun Pharmaceuticals has taken action on the drug recall by recalling 5,488 bottles of Lisdexamfetamine Dimesylate that used to be a central nervous system (CNS) stimulant vital for the management of ADHD in both adults and children aged six and above.
This voluntary drug recall, as detailed in the latest enforcement report from the U.S. Food and Drug Administration (USFDA), specifically targets 5,488 bottles of the medication.
These capsules were manufactured by OHM Laboratories, located in New Brunswick.
Reason behind the drug recall:
The reason behind this drug recall is a manufacturing deviation: “an out-of-specification result observed in a dissolution test during analysis at a 9-month long-term stability station (25°C, 60% RH).”
Simply, it can be said that during routine stability testing, the drug failed to dissolve at the expected rate under controlled conditions after a nine-month period.
This is a Class II drug recall
The USFDA has classified this voluntary action as a Class II drug recall, a designation that carries specific implications for both consumers and distributors.
Initiated by Sun Pharmaceuticals on June 16, 2025, this classification signifies a situation where the “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Q: What is meant by “Dissolution Specifications” ?
A: “Dissolution Specifications” refer to the rate and extent to which the active ingredient of a drug dissolves from its dosage form into a solution under controlled laboratory conditions.
Q: What is a Class II drug recall?
A: A Class II drug recall, according to the USFDA, means that “use of or exposure to a violative drug may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
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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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