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Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bo...

FDA Recall #D-1217-2018 — Class II — September 4, 2018

Recall #D-1217-2018 Date: September 4, 2018 Classification: Class II Status: Terminated

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

Reason for Recall

Cross Contamination With Other Products:

Recalling Firm

Boehringer Ingelheim Pharmaceuticals, Inc. — Ridgefield, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

998 180-count bottles

Distribution

Nationwide

Code Information

Lot # 603968 EXP 4/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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