New Delhi: Drug makers Dr Reddy’s Laboratories, Sun Pharma and Aurobindo Pharma are recalling their products in the US 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) due to it being a ‘Sub-potent Drug’. Sapropterin dihydrochloride is used to treat hyperphenylalaninemia (HPA), which is characterised by elevated amounts of phenylalanine in the blood.
Dr Reddy’s Laboratories is also recalling an additional lot of sapropterin dihydrochloride for the same reason. As per USFDA, the drug maker started the Class I recall in the US April 8.
In addition, the USFDA mentioned that Sun Pharma is recalling 11,016 vials of Amphotericin B Liposome for Injection, which is used to treat fungal infections. The drug maker initiated the Class II recall April 19 due to being “Out of specification for assay”.
Similarly, Aurobindo Pharma is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg) from the US market. Clorazepate Dipotassium Tablets are used to treat anxiety.
According to the USFDA, the recall is due to “Discoloration: Dotted and yellow spots on tablets”. The company began the Class II recall April 24.
Additionally, the USFDA mentioned that FDC Ltd is recalling 382,104 units of Timolol Maleate Ophthalmic Solution, which is used to treat glaucoma. The drug maker is recalling the affected lot due to a “Defective Container”.
Earlier this month, drug makers Cipla and Glenmark recalled their products from the US market due to manufacturing issues.
IANS
