Indian pharmaceutical companies, including Dr Reddy’s Laboratories, Sun Pharma, and Aurobindo Pharma, have initiated product recalls in the US market due to manufacturing issues. According to the latest Enforcement Report by the US Food and Drug Administration (USFDA), these recalls stem from concerns about product quality and compliance with safety standards.
Dr Reddy’s Laboratories has recalled nearly 20,000 cartons of Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg), which is used to control blood phenylalanine levels in adults and children. The Princeton, New Jersey-based arm of Dr Reddy’s initiated this recall because the drug was found to be sub-potent. This Class I recall, which was started on April 8, 2023, involves defective products that can cause serious health problems.
Sun Pharma’s Amphotericin B Liposome Recall
Sun Pharma is also recalling 11,016 vials of Amphotericin B Liposome for Injection, a medication used to treat fungal infections, from the US market. This recall was initiated on April 19, 2023, and is classified as a Class II recall due to the product being out of specification for assay. Class II recalls are issued when a violative product may cause temporary or medically reversible adverse health consequences, with a remote probability of serious health issues.
Aurobindo Pharma’s Clorazepate Dipotassium Recall
Similarly, Aurobindo Pharma has recalled 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg), which are used to treat anxiety. This recall was initiated on April 24, 2023, because the tablets were found to have discoloration, with dotted and yellow spots. This recall is also classified as Class II by the USFDA.
FDC Ltd’s Timolol Maleate Ophthalmic Solution Recall
Another pharmaceutical company, FDC Ltd, based in Aurangabad, Maharashtra, has recalled 3,82,104 units of Timolol Maleate Ophthalmic Solution, which is used to treat glaucoma. The recall was due to defective containers and was also classified as Class II.
Impact on the US Generic Drug Market
The US generic drug market, valued at approximately USD 115.2 billion in 2019, is the largest market for pharmaceutical products. These recalls highlight the ongoing challenges faced by pharmaceutical companies in maintaining stringent quality standards in the highly regulated US market. Ensuring compliance with the USFDA’s safety and quality requirements is crucial for these companies to sustain their market presence and protect consumer health.
