Synjardy Tablet, Extended Release
FDA Recall NDC 0597-0295
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Synjardy (NDC 0597-0295). A significant event, classified as Class II, was initiated on Mar 15, 2021 by Boehringer Ingelheim Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP Deviations: Intermittent exposure to temperature excursion during storage."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
269 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
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
Batch or Lot Expiration Information
Lot# 3191432
Affected Packages Involved in this Recall
0597-0280-36Product
0597-0280-73Product
0597-0280-90Product
0597-0290-20Product
0597-0290-59Product
0597-0290-74Product
0597-0295-61Product
0597-0295-78Product
0597-0295-88Product
0597-0300-20Product
0597-0300-45Product
0597-0300-93Product
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
751 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
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
Batch or Lot Expiration Information
Lot# 3190949
Affected Packages Involved in this Recall
0597-0280-36Product
0597-0280-73Product
0597-0280-90Product
0597-0290-20Product
0597-0290-59Product
0597-0290-74Product
0597-0295-61Product
0597-0295-78Product
0597-0295-88Product
0597-0300-20Product
0597-0300-45Product
0597-0300-93Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
