Why it was recalled
Cross Contamination With Other Products:
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
Lot numbers, UPCs & expiration codes
Lot # 603968 EXP 4/2019
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1217-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 4, 2018
- FDA report date
- Oct 3, 2018
- Quantity
- 998 180-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1217-2018, exactly as published.
Show all FDA fields
- City
- Ridgefield
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 80961
- Address
- 900 Ridgebury Rd
- Code information
- Lot # 603968 EXP 4/2019
- Postal code
- 06877-1058
- Report date
- Oct 3, 2018
- Product type
- Drugs
- Recall number
- D-1217-2018
- Classification
- Class II
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Product quantity
- 998 180-count bottles
- Termination date
- Aug 19, 2019
- Reason for recall
- Cross Contamination With Other Products:
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 4, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 27, 2018