Drug recall D-0456-2021
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.
Lots and codes
C80102
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 284 bottles
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- NDC 0597-0168 Synjardy · Empagliflozin 12.5 mg/1; Metformin Hydrochloride 1000 mg/1 · Boehringer Ingelheim Pharmaceuticals, Inc.