US drug recalls for Sun Pharma, Lupin, and Dr. Reddy’s due to quality concerns

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US drug recalls for Sun Pharma, Lupin, and Dr. Reddy's due to quality concerns

According to the most recent enforcement report from the US Food and Drug Administration (USFDA), Indian pharmaceutical companies Sun Pharma, Lupin, and Dr. Reddy’s Laboratories are recalling some of their medications from the US market because of production issues and product mix-ups.

A generic medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) is being recalled in 5,448 bottles by Mumbai-based Sun Pharmaceutical Industries.

Lisdexamfetamine Dimesylate capsules are the medication in concern; during testing, they did not dissolve according to the necessary criteria.

On June 16, Princeton-based Sun Pharmaceutical Industries Inc., Sun’s US subsidiary, announced the recall. This recall is categorized as a Class II recall by the USFDA.

Another well-known pharmaceutical company, Lupin, with headquarters in Mumbai, is recalling 58,968 bottles of a generic medication for high blood pressure.

The medication, a mix of hydrochlorothiazide and lisinopril tablets, was produced at Lupin’s Nagpur plant and was recalled by its US subsidiary, Lupin Pharmaceuticals Inc., which is headquartered in Naples.

Following a complaint that a sealed container of the blood pressure medication included a separate medication—a pill of Atazanavir and Ritonavir, used to treat HIV—the recall got underway on June 20.

The USFDA categorized this as a Class II recall and called it a “Product Mix Up” case.

Omeprazole delayed-release capsules, which are frequently used to treat issues with the stomach and oesophagus, are being recalled in 1,476 bottles by Dr. Reddy’s Laboratories in a related case.

The USFDA claims that Dr. Reddy’s Princeton-based US unit started the recall on June 30. The company’s Bachupally plant in India produced the impacted lot.

The recall was caused by the discovery of foreign pills, notably extended-release Divalproex Sodium tablets, in bottles that were intended to exclusively contain Omeprazole capsules.

When using a defective product may result in short-term or medically reversible health concerns but the likelihood of major health issues is minimal, the USFDA states that a Class II recall is issued.

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