Drug firm Dr Reddy's Laboratories' US arm is recalling 3,342 vials of anti-osteoporosis injection, made by Hyderabad-based Gland Pharma, on account of lack of assurance of sterility.
The recall is being carried out by Dr Reddy's Laboratories Inc for 5 mg/100 mL (0.05 mg/mL), 100 mL single use bottle of Zoledronic Acid, as per information available on USFDA site.
Gland Pharma is producing the injection at its Dundigal facility in India.
"The reason for recall is lack of assurance of sterility; defective seals where the metal silver ring was not attached tightly to the vial," United States Food and Drug Administration (USFDA) added.
The ongoing nationwide voluntary Class II recall covers 3,342 vials of the medicine.
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".
