Drug recall D-0459-2021
Product
Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
3190949
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 751 bottles
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Synjardy – drug information
- NDC 0597-0290 Synjardy XR · Empagliflozin 5 mg/1; Metformin Hydrochloride 1000 mg/1 · Boehringer Ingelheim Pharmaceuticals, Inc.
- NDC 0597-0280 Synjardy XR · Empagliflozin 10 mg/1; Metformin Hydrochloride 1000 mg/1 · Boehringer Ingelheim Pharmaceuticals, Inc.
- NDC 0597-0300 Synjardy XR · Empagliflozin 12.5 mg/1; Metformin Hydrochloride 1000 mg/1 · Boehringer Ingelheim Pharmaceuticals, Inc.
- NDC 0597-0295 Synjardy XR · Empagliflozin 25 mg/1; Metformin Hydrochloride 1000 mg/1 · Boehringer Ingelheim Pharmaceuticals, Inc.