Product: 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
Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated: 20210315
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated