FDA DrugClass IINotable
FDA Recall: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000
Description
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.
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.
Remedy
560 bottles
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