Indian Drug Makers Recall Products In US Over FDA Concerns

In a major development affecting the pharmaceutical industry, three major Indian drug makers – Dr Reddy's Laboratories, Sun Pharma, and Aurobindo Pharma – are recalling several products in the US market. These actions come in response to manufacturing issues identified by the US Food and Drug Administration (USFDA according to the latest Enforcement Report.

Dr Reddy's Laboratories, with its base in Princeton, New Jersey, is recalling approximately 20,000 cartons of Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg). This medication is crucial for controlling blood phenylalanine levels in adults and children but has been deemed 'Sub-potent' by the USFDA, PTI reported.

The recall, classified as Class I, started on April 8, indicating that the product could potentially cause serious health issues. Also, another lot of sapropterin dihydrochloride is being recalled for the same potency issue.

Meanwhile, Sun Pharma has initiated a Class II recall for 11,016 vials of Amphotericin B Liposome for Injection, a treatment for fungal infections. This recall, which began on April 19, arises from the product being 'Out of specification for assay', as stated by the USFDA.

Aurobindo Pharma is also participating in a recall, pulling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg) from the US market. Used to manage anxiety, these tablets have shown 'Discoloration: Dotted and yellow spots,' prompting a Class II recall that commenced on April 24.

Additionally, FDC Ltd, a firm based in Aurangabad, Maharashtra, is recalling 3,82,104 units of Timolol Maleate Ophthalmic Solution, utilized for glaucoma treatment. The recall is due to a 'Defective Container' and falls under the Class II category, which involves products that may lead to temporary or medically reversible adverse health consequences.

The US generic drug market, valued at approximately USD 115.2 billion in 2019, serves as the largest global market for pharmaceutical products. These recalls underscore the importance of stringent quality control and regulatory compliance in the pharmaceutical industry, especially in markets with high standards such as the United States.