Dr. Reddy's, Sun Pharma, Aurobindo recall products in US
Pharmaceutical companies Dr. Reddy's Laboratories, Sun Pharma, and Aurobindo Pharma are recalling several products from the United States (US) market due to manufacturing issues. Dr. Reddy's Laboratories is recalling nearly 20,000 cartons of Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg), a medication used to control blood phenylalanine levels in adults and children. The reason for this recall is that it is a "sub-potent drug," the US Food and Drug Administration (USFDA) said.
Additional recalls initiated by Dr. Reddy's Laboratories
In addition to the Javygtor recall, Dr. Reddy's Laboratories is also recalling another lot of sapropterin dihydrochloride for the same reason. According to the USFDA, the drug maker initiated the Class I recall in the US on April 8 this year. The Class I recall pertains to defective products that can cause serious health problems, the US health regulator said.
Sun Pharma recalls fungal infection medication
Sun Pharma is recalling 11,016 vials of Amphotericin B Liposome for injection. This medication is used to treat fungal infections. The company's US-based arm initiated the Class II recall on April 19 this year due to "out of specification for assay," as per the USFDA. A Class II recall is initiated when the use of a violative product may cause temporary or medically reversible adverse health consequences.
Aurobindo Pharma recalls anxiety medication in US
Aurobindo Pharma is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75mg and 7.5mg), which are used to treat anxiety. The company's US-based arm is recalling these products due to "Discoloration: Dotted and yellow spots on tablets." The Class II recall was initiated on April 24 this year. Meanwhile, FDC Ltd is recalling 382,104 units of Timolol Maleate Ophthalmic Solution, a medication used to treat glaucoma. The recall is due to a "Defective Container," the USFDA stated.
