Apotex Inc. recalls CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M…

Recall date

February 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0475-2017

FDA classification

Class II

Brand / firm

Apotex Inc.

Sold / distributed

Distributed Nationwide

Why it was recalled

Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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