Synjardy Tablet
FDA Recall NDC 0597-0175
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Synjardy (NDC 0597-0175). A significant event, classified as Class II, was initiated on Sep 04, 2018 by Boehringer Ingelheim Pharmaceuticals, Inc.. The reported reason for this action was: "Cross Contamination With Other Products:"
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
Cross Contamination With Other Products:
Sep 04, 2018
Oct 03, 2018
998 180-count bottles
Recall Profile & Regulatory Data
Event ID
80961
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Boehringer Ingelheim Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 19, 2019
Product Description
Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC 0597-0175-18
Batch or Lot Expiration Information
Lot# 603968 EXP 4/2019
Affected Packages Involved in this Recall
0597-0159-60Product
0597-0159-18Product
0597-0159-66Product
0597-0175-60Product
0597-0175-18Product
0597-0175-66Product
0597-0180-60Product
0597-0180-18Product
0597-0180-66Product
0597-0168-60Product
0597-0168-18Product
0597-0168-66Product
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.
