Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

Recall Number: D-0456-2021

Firm: Cardinal Health Inc.

Classification: Class II

Status: Terminated

Report Date: 20210602

Initiation Date: 20210315

Termination Date: 20240617

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA