RecallDepth
Class II Terminated

Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

Company
Cardinal Health Inc.
Recall Initiated
March 15, 2021
Posted
June 2, 2021
Recall Number
D-0459-2021
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
751 bottles
Firm Location
Dublin, OH, United States

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Distribution

FL, GA, SC

Lot / Code Info

3190949

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