September 2018 FDA Recall Synjardy by Boehringer Ingelheim Pharmaceuticals, Inc.
D-1217-2018 - Cross Contamination With Other Products
This Class II drug recall was voluntarily initiated by Boehringer Ingelheim Pharmaceuticals, Inc. on September 4, 2018 for the product Synjardy. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1217-2018
Cross Contamination With Other Products:
09-04-2018
10-03-2018
998 180-count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Boehringer Ingelheim Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-19-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 603968 EXP 4/2019
