FDA Drug Moderate Class II Terminated

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

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0592-2021

Product Description

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm: Cardinal Health Inc.
Units Affected: 271 bottles
Distribution: FL, GA, SC
Location: Dublin, OH

Frequently Asked Questions

What product was recalled? ▼

Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00. Recalled by Cardinal Health Inc.. Units affected: 271 bottles.

Why was this product recalled? ▼

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0592-2021.