Prominent Indian drug makers Dr Reddy’s Laboratories, Sun Pharma, and Aurobindo Pharma have initiated recalls of several products from the US market due to manufacturing issues, according to the latest Enforcement Report by the US Food and Drug Administration (USFDA).
Dr Reddy’s Laboratories, based in Princeton, New Jersey, is recalling its Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg) due to it being identified as a “Sub-potent Drug.” The USFDA also noted that another lot of sapropterin dihydrochloride is being recalled for the same reason. The company commenced the Class I recall on April 8 this year. A Class I recall is the most serious type of recall, indicating that use of the drug could cause serious health problems or death.
Sun Pharma is recalling 11,016 vials of Amphotericin B Liposome for Injection, a treatment for fungal infections, from the US market. The recall, categorized as Class II, was initiated on April 19 this year due to the product being “Out of specification for assay.” A Class II recall is initiated when use of or exposure to a product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Similarly, Aurobindo Pharma is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg), which are used to treat anxiety. This Class II recall was initiated on April 24 due to “Discoloration: Dotted and yellow spots on tablets.”
Additionally, another pharmaceutical firm, FDC Ltd, is recalling 382,104 units of Timolol Maleate Ophthalmic Solution, a treatment for glaucoma, due to a “Defective Container.” This recall also falls under the Class II category.
The USFDA’s classification of recalls helps to inform consumers and healthcare professionals about the potential risks associated with these products. The US generic drug market, valued at approximately USD 115.2 billion in 2019, is the largest market for pharmaceutical products, making these recalls significant for both the companies involved and the market at large.
These recalls highlight ongoing challenges in maintaining stringent manufacturing standards in the pharmaceutical industry, emphasizing the critical need for continuous quality control and compliance with regulatory requirements to ensure patient safety.
