Product Safety Recalls

Product Recall Tracker

SIROLIMUS Recall D-0881-2022

Description: Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2

SIROLIMUS Recall D-0881-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0881-2022
Event ID90114
BrandSIROLIMUS
Generic NameSIROLIMUS
ManufacturerSIROLIMUS
Original Package?1
Active SubstanceSIROLIMUS
Drug RouteORAL
DistributionNationwide in the USA
Quantity2353 bottles
Recall ReasonFailed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Drug ClassificationClass III
Drug Code Info20220525
Product NDC60505-6197
Product NUIN0000175550 N0000175625 N0000175624
Pharma Class (PE)Decreased Immunologic Activity [PE]
Pharma Class (EPC)mTOR Inhibitor Immunosuppressant [EPC]
Recall Initiation Date20220503
Report Date20220525
Classification Date20220518
Address2400 N Commerce Pkwy Ste 400
Weston, FL 33326-3253
United States
Recalling FirmApotex Corp.
Initial Notification Letter
Unique Ingredient IdentifierW36ZG6FT64
Drug Application NumberANDA211406
Structured Product Labeling (SPL ID)0735534c-0f71-1400-5d87-fc99fc30a11d
Structured Product Labeling (SPL Set ID)9f64692d-2a18-ffcb-c572-0f218a71ca67
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.