Recalls / Class II
Class IID-1217-2018
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
- Brand name
- Synjardy
- Generic name
- Empagliflozin And Metformin Hydrochloride
- Active ingredients
- Empagliflozin, Metformin Hydrochloride
- Route
- Oral
- NDCs
- 0597-0159, 0597-0175, 0597-0180, 0597-0168
- FDA application
- NDA206111
- Affected lot / code info
- Lot # 603968 EXP 4/2019
Why it was recalled
Cross Contamination With Other Products:
Recalling firm
- Firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 900 Ridgebury Rd, Ridgefield, Connecticut 06877-1058
Distribution
- Quantity
- 998 180-count bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-09-04
- FDA classified
- 2018-09-27
- Posted by FDA
- 2018-10-03
- Terminated
- 2019-08-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1217-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.