Drug product
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
D-0657-2026
Product summary
- Event
- Event 99233
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 560 bottles
- Official record key
drug-enforcement:D-0657-2026
Official wording
Reason: 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.
Code information: Lot 3244413; Exp. 12/31/2028
Distribution pattern: OH
Derived failure modes
-
Manufacturing or process control
CGMP Deviations