As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
New Delhi:
Drug makers Dr Reddy’s Laboratories, Sun Pharma and Aurobindo Pharma are recalling products in the US market due to manufacturing issues, as per the latest Enforcement Report of the US Food and Drug Administration (USFDA).
Dr Reddy’s Laboratories is recalling close to 20,000 cartons of a medication used to control blood phenylalanine levels in adults and children.
Princeton (New Jersey) based Dr Reddy’s Laboratories, Inc, is recalling Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg) due to it being a “Sub-potent Drug”, USFDA stated.
The company is also recalling another lot of sapropterin dihydrochloride for the same reason, it added. The USFDA said the drug maker initiated the Class I recall in the US on April 8 this year.As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems.
The USFDA said Sun Pharma is recalling 11,016 vials of Amphotericin B Liposome for Injection, used to treat fungal infections, in the US market.
The company’s US-based arm initiated the Class II recall on April 19 this year due to “Out of specification for assay”, the USFDA stated.
Similarly, “Aurobindo Pharma is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg), used to treat anxiety, in the American market. The company’s US-based arm is recalling the affected lot due to “Discoloration: Dotted and yellow spots on tablets”, USFDA stated.
The company initiated the Class II recall on April 24 this year.
The USFDA stated that another drug firm FDC Ltd is recalling 3,82,104 units of Timolol Maleate Ophthalmic Solution, used to treat glaucoma, in the American market.
The Aurangabad (Maharashtra)-based drug firm is recalling the affected lot due to “Defective Container”.
As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The US generic drug market, estimated to be around USD 115.2 billion in 2019, is the largest market for pharmaceutical products.