FDA recall D-1217-2018

Boehringer Ingelheim Pharmaceuticals, Inc. · Class II · 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

Reason for recall

Cross Contamination With Other Products:

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2018-09-04
Report date: 2018-10-03
Termination date: 2019-08-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ridgefield, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1217-2018