Class II
Terminated
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
This recall has been terminated (originally issued June 2, 2021).
- Company
- Cardinal Health Inc.
- Recall Initiated
- March 15, 2021
- Posted
- June 2, 2021
- Recall Number
- D-0459-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 751 bottles
- Firm Location
- Dublin, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution
FL, GA, SC
Lot / Code Info
3190949
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