Multiple Indian Drugmakers Recall Products in the US Over Quality Concerns 

coronavirus drugs


In a concerning development for the Indian pharmaceutical industry, several leading Indian drug manufacturers, including Dr Reddy’s Laboratories, Sun Pharma, and Aurobindo Pharma, have initiated recalls of their products in the United States due to manufacturing issues.

According to the latest Enforcement Report by the US Food and Drug Administration (USFDA), Dr Reddy’s Laboratories is recalling Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg).

This medication is used to treat hyperphenylalaninemia (HPA), characterized by elevated phenylalanine levels in the blood. The recall is due to Javygtor being identified as a “Sub-potent Drug.” An additional lot of sapropterin dihydrochloride is also being recalled for the same reason.

USFDA stated that the drug maker started the Class I recall in the US on April 8.

Sun Pharma, another major player, is recalling 11,016 vials of its antifungal injection Amphotericin B Liposome that did not meet quality standards. The recall was initiated due to the product being “Out of specification for assay”, the USFSA said.

Aurobindo Pharma is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg), used to treat anxiety. The recall is attributed to “Discoloration: Dotted and yellow spots on tablets.” The company started the Class II recall on April 24.

Similarly, Aurobindo Pharma is recalling 13,605 bottles of anti-anxiety medication Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg) due to discolored tablets. Discoloration can be a sign of degradation or contamination, raising concerns about the medication’s safety and effectiveness. FDC Ltd is also facing a recall for its glaucoma medication due to faulty containers. Faulty containers could compromise the medication’s sterility, potentially leading to infections.

FDC Ltd is recalling 382,104 units of Timolol Maleate Ophthalmic Solution, used to treat glaucoma. The reason for the recall is a “Defective Container” based on complaints from patients reporting difficulty in getting the product solution out of the bottle due to the spike of the cap. This recall is termed as a precautionary measure as it is not likely to adversely impact health consequences.

Earlier this month, drug makers Cipla and Glenmark also recalled their products from the US market due to manufacturing issues.


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