New Delhi: Pharmaceuticals major Dr. Reddy’s Laboratories (DRL) has recalled a single lot of Docetaxel injection vials, used for the treatment of breast cancer, USFDA has said.
As per the US health regulator’s enforcement report for the week of January 17, a single lot of 1,051 vials of Docetaxel injection USP, 20 mg/mL was distributed in the US, Uzbekistan, and Myanmar.
The company has recalled the drug on account of a defective container, the report said.
“Product complaints received of a defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off,” it said.
The vials were manufactured by Dr Reddy’s Laboratories at its Visakhapatnam facility, the United States Food and Drug Administration has said.
The voluntary ongoing recall is a class II recall, the regulator said.
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”.