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Recall Observatory FDA recall evidence

Drug product

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

D-1217-2018

September 04, 2018

Class II

Product summary

Firm
Boehringer Ingelheim Pharmaceuticals, Inc.
Event
Event 80961
Status
Terminated
Classification
Class II
Quantity
998 180-count bottles
Official record key
drug-enforcement:D-1217-2018

Official wording

Reason: Cross Contamination With Other Products:

Code information: Lot # 603968 EXP 4/2019

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross Contamination With Other Products: