United StatesSynjardy XR tablets (empagliflozin and metformin hydrochloride) 12.5/1000 mg, 60 tablets per bottle, Rx only (NDC 00597-0300-45), Lot 3244413, Exp. 12/31/2028, distributed by Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, were sold in OH (560 bottles). They were recalled because of CGMP deviations: an incorrect detergent was used and required swab sampling was not performed on a production hopper that had previously been used for a different product.
What's being recalled
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45
Recalling firm: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States.
How to identify it
Lot 3244413; Exp. 12/31/2028
The hazard
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
OH
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)