FDA-Drug2021-06-02Class II

Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00

Cardinal Health Inc.
Hazard

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Sold states
FL, GA, SC
Affected count
271 bottles
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0592-2021

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