New Delhi: Drug makers Dr Reddy's Laboratories, Sun Pharma and Aurobindo Pharm are recalling their products 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 around 20,000 cartons of the medicine, used to control phenylalanine levels in the blood in adults and children.
Dr. Reddy's Laboratories, Inc., based in Princeton (New Jersey), is recalling Zavigo (sapropterin dihydrochloride) powder for oral solution (100 mg) due to being a "sub-potent drug," the USFDA said.
The company is also withdrawing another consignment of Sapropterin Dihydrochloride for the same reason. The USFDA said the drugmaker had initiated the class recall in the US on April 8 this year.According to the US health regulator, Class I recalls relate to a defective product 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 USFDA said the US-based arm of the company initiated the Class II recall on April 19 this year due to "out of specification for assay".
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 US market. The US-based arm of the company is recalling discoloration: dotted and yellow The reason is taking back the affected lots.stains on the tablets”, the USFDA said.
The company initiated the Class II recall on April 24 this year.
Another drugmaker, FDC Ltd, is recalling 3,82,104 units of Timolol Maleate Ophthalmic Solution, used to treat glaucoma, in the US market, the USFDA said.
The Aurangabad (Maharashtra)-based pharmaceutical company is recalling Lot Du affected by "defective containers".
According to the USFDA, a Class II recall is initiated in a situation where use of or exposure to a violative product is likely to cause temporary or medically significant adverse health consequences or where the likelihood of serious adverse health consequences is low.The US generic drug market, estimated to be worth approximately US$115.2 billion in 2019, is the largest market for pharmaceutical products.
Dr. Reddy's Laboratories is recalling around 20,000 cartons of the medicine, used to control phenylalanine levels in the blood in adults and children.
Dr. Reddy's Laboratories, Inc., based in Princeton (New Jersey), is recalling Zavigo (sapropterin dihydrochloride) powder for oral solution (100 mg) due to being a "sub-potent drug," the USFDA said.
The company is also withdrawing another consignment of Sapropterin Dihydrochloride for the same reason. The USFDA said the drugmaker had initiated the class recall in the US on April 8 this year.According to the US health regulator, Class I recalls relate to a defective product 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 USFDA said the US-based arm of the company initiated the Class II recall on April 19 this year due to "out of specification for assay".
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 US market. The US-based arm of the company is recalling discoloration: dotted and yellow The reason is taking back the affected lots.stains on the tablets”, the USFDA said.
The company initiated the Class II recall on April 24 this year.
Another drugmaker, FDC Ltd, is recalling 3,82,104 units of Timolol Maleate Ophthalmic Solution, used to treat glaucoma, in the US market, the USFDA said.
The Aurangabad (Maharashtra)-based pharmaceutical company is recalling Lot Du affected by "defective containers".
According to the USFDA, a Class II recall is initiated in a situation where use of or exposure to a violative product is likely to cause temporary or medically significant adverse health consequences or where the likelihood of serious adverse health consequences is low.The US generic drug market, estimated to be worth approximately US$115.2 billion in 2019, is the largest market for pharmaceutical products.
