Dr. Reddy's, Sun Pharma, Aurobindo recall medicine in the US
What's the story
Three major pharmaceutical companies, Dr. Reddy's Laboratories, Sun Pharma, and Aurobindo Pharma, are recalling several products from the United States due to manufacturing issues.
This information was revealed in the latest enforcement report of the US Food and Drug Administration (USFDA).
Specifically, Dr Reddy's Laboratories, based in Princeton, New Jersey, has initiated a recall for around 20,000 cartons of a medication, used to control blood phenylalanine levels in adults and children.
Urgent
Dr Reddy's initiated Class I recall
Dr Reddy's is recalling Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg) because it is a "Sub-potent Drug," as stated by the USFDA.
The recall was initiated on April 8 this year, and it has been classified as a Class I recall by the USFDA.
Class I recalls are those pertaining to defective products that can potentially cause serious health problems.
In addition to Javygtor, the firm is also recalling another lot of sapropterin dihydrochloride for being "Sub-potent."
Additional recalls
Sun Pharma and Aurobindo Pharma initiated Class II recall
Sun Pharma is also recalling goods in the US, specifically 11,016 vials of Amphotericin B Liposome for Injection, used to treat fungal infections.
This was a Class II recall initiated by Sun Pharma's US-based arm on April 19, due to "Out of specification for assay," per USFDA.
Meanwhile, Aurobindo Pharma initiated a Class II recall for 13,605 bottles of Clorazepate Dipotassium Tablets (3.75mg, 7.5mg), used to treat anxiety due to "Discoloration: Dotted and yellow spots on tablets."