Cardinal Health Inc. recalls Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC
Recalled June 2, 2021 · FDA recall D-0459-2021 · Cardinal Health
Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage. · FDA Class II
Units
751 bottles
Sold at
FL, GA, SC
Description
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product
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
Manufacturer(s)
Cardinal Health Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →