FDA Recall Terminated Historical recordClass II
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
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
