Apotex Inc. recalls CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Ma
Recalled March 1, 2017 · FDA recall D-0475-2017 · Apotex
Hazard
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities. · FDA Class II
Units
19,584 bottles
Sold at
Distributed Nationwide
Description
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Product
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
Manufacturer(s)
Apotex Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →