D-0458-2021 Class II Terminated
FDA drug recall D-0458-2021 was initiated by Cardinal Health Inc. on March 15, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage. The recall status is terminated (terminated June 17, 2024). Affected quantity: 269 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 2, 2021
- Initiation Date
- March 15, 2021
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 269 bottles
Product Description
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
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution Pattern
FL, GA, SC
Code Information
3191432