Mumbai, July 27 Indian pharmaceutical companies Sun Pharma, Lupin, and Dr Reddy’s Laboratories are recalling some of their medicines from the US market due to manufacturing problems and product mix-ups, as per the US Food and Drug Administration (USFDA) latest enforcement report.
Sun Pharmaceutical Industries, headquartered in Mumbai, is recalling 5,448 bottles of a generic drug used to treat Attention Deficit Hyperactivity Disorder (ADHD).
The medicine in question is Lisdexamfetamine Dimesylate capsules, which failed to meet the required dissolution standards during testing.
The recall was initiated by Sun’s US arm, Princeton-based Sun Pharmaceutical Industries Inc., on June 16. The USFDA has classified this as a Class II recall.
Lupin, another leading drug maker based in Mumbai, is recalling 58,968 bottles of a generic medicine used to treat high blood pressure.
The medicine, a combination of Lisinopril and Hydrochlorothiazide tablets, was manufactured at Lupin’s Nagpur facility and recalled by its US unit, Lupin Pharmaceuticals Inc, based in Naples.
The recall began on June 20, following a complaint that a sealed bottle of the blood pressure drug contained a different medicine — a tablet of Atazanavir and Ritonavir, used for HIV treatment.
The USFDA termed this a case of “Product Mix Up” and also classified it under Class II recall.
In a similar case, Dr Reddy’s Laboratories is recalling 1,476 bottles of Omeprazole delayed-release capsules, which are commonly used to treat stomach and oesophagus problems.
According to the USFDA, the recall was initiated by Dr Reddy’s US unit based in Princeton on June 30. The affected lot was manufactured at the company’s Bachupally plant in India.
The reason for the recall was the presence of foreign tablets — specifically, Divalproex Sodium extended-release tablets — found in bottles that were supposed to contain only Omeprazole capsules.
According to the USFDA, a Class II recall is issued when the use of a defective product may cause temporary or medically reversible health problems, but the chances of serious health issues are low.
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