Months after the Indian-made cough syrups were linked to 141 children's deaths worldwide forcing the manufacturers to recall their products, it has been found that major pharma companies Dr Reddy's Laboratories, Sun Pharma, and Aurobindo Pharma are recalling their drugs 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 is recalling nearly 20,000 cartons of a medication used to control blood phenylalanine levels in adults and children. Dr Reddy's Laboratories, Inc, based in Princeton, New Jersey, is recalling Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg) because it is sub-potent, according to the USFDA. The company is also recalling another lot of sapropterin dihydrochloride for the same reason, as per reports.
Sapropterin dihydrochloride is used to treat hyperphenylalaninemia (HPA), a condition characterized by high levels of phenylalanine in the blood. It is specifically indicated for individuals with phenylketonuria (PKU), a genetic disorder in which the body cannot break down the amino acid phenylalanine, leading to its accumulation in the blood.
High levels of phenylalanine can cause various health problems, including intellectual disabilities, developmental delays, and other neurological issues.
The USFDA stated that the company initiated the Class I recall on April 8 this year. A Class I recall, as defined by the US health regulator, pertains to defective products that can cause serious health problems.
The USFDA also reported that Sun Pharma is recalling 11,016 vials of Amphotericin B Liposome for Injection, used to treat fungal infections, from the US market. Sun Pharma's US-based arm initiated the Class II recall on April 19 this year due to being “Out of specification for assay,” according to the USFDA.
Similarly, Aurobindo Pharma is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg), used to treat anxiety, from the US market. The recall is due to “Discoloration: Dotted and yellow spots on tablets,” as stated by the USFDA. Aurobindo Pharma's US-based arm initiated the Class II recall on April 24 this year. Additionally, the USFDA reported that FDC Ltd is recalling 382,104 units of Timolol Maleate Ophthalmic Solution, used to treat glaucoma, from the US market.
The Aurangabad, Maharashtra-based drug firm is recalling the affected lot due to a “Defective Container.” According to the USFDA, a Class II recall is initiated when the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
Last October India's drug regulator had found that a cough syrup and an anti-allergy syrup made by Norris Medicines (NORI.BO), were toxic, according to a government report, months after its made cough syrups were linked to 141 children's deaths worldwide.
The medicines were contaminated either with diethylene glycol (DEG) or ethylene glycol (EG), the same contaminants found in the cough syrups that caused the deaths in Gambia, Uzbekistan and Cameroon since the middle of last year. Similarly, the CDSCO also found three batches of COLD OUT syrup made by Fourrts (India) Laboratories contaminated with DEG and EG.
The US generic drug market, valued at approximately $115.2 billion in 2019, is the largest market for pharmaceutical products.
