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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

Mandated?Voluntary: Firm initiated
Recall NumberD-0881-2022
Event ID90114
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
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