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Cardinal Health Inc. recalls Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 05

Recalled June 2, 2021 · FDA recall D-0458-2021 · Cardinal Health

Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage. · FDA Class II
Units
269 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 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 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