Class III · Low risk Ongoing
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made…
Reason Failed Impurities/Degradation Specifications
Is Sirolimus recalled?
8 FDA recalls mention Sirolimus. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sirolimus.
Class III · Low risk Terminated
Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50…
Reason Failed Stability Specifications
Class III · Low risk Terminated
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.
Class III · Low risk Terminated
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
Class III · Low risk Terminated
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.
Class III · Low risk Terminated
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…
Class II · Moderate risk Terminated
SIROLIMUS, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008104105.
Reason Labeling: Label Mixup: SIROLIMUS, Tablet, 1 mg may be potentially mislabeled as one of the following drugs: PROPRANOLOL HCL, Tablet, 10 mg, NDC…
Class III · Low risk Terminated
TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection…
Reason Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
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