FDA-Drug2021-06-02Class II
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
Cardinal Health Inc.
Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Sold states
FL, GA, SC
Affected count
269 bottles
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0458-2021Don't want to check this manually?
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