Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Dr. Reddy's Laboratories, Inc.

NDC code

55111-653-01

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0504-2024

Other Sirolimus recalls

See all

Class III · Low risk Terminated Oct 13, 2022

Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50…

Reason Failed Stability Specifications

Aadi Bioscience NDC 80803-153-50 D-0059-2023

Class III · Low risk Terminated May 3, 2022

Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9…

Reason Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

Apotex Corp. NDC 60505-6197-2 D-0881-2022

Class III · Low risk Terminated May 12, 2021

Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health…

Reason Failed Impurities/Degradation Specifications

American Health Packaging NDC 68084-915-25 D-0813-2021

Class III · Low risk Terminated Jun 3, 2016

Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046…

Reason Failed impurities/degradation: out of specification result for impurity secorapamycin.

Dr. Reddy's Laboratories, Inc. NDC 55111-653-01 D-1063-2016

Class III · Low risk Terminated Oct 10, 2014

TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only…

Reason Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold…

Pfizer Inc. NDC 0008-1179-01 D-0235-2015