FDA-Drug2017-03-01Class II
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0
Apotex Inc.
Hazard
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Sold states
Distributed Nationwide
Affected count
19,584 bottles
Manufactured in
150 Signet Dr, N/A, North York, N/A, Canada
Products
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0475-2017Don't want to check this manually?
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