Product Safety Recalls

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GLIMEPIRIDE Recall D-0551-2023

Description: Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

GLIMEPIRIDE Recall D-0551-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0551-2023
Event ID91944
Active SubstanceGLIMEPIRIDE
Drug RouteORAL
DistributionNationwide with the United States
Quantitya) 230 bottles; b) 22 bottles
Recall ReasonCGMP Deviations
Drug ClassificationClass II
Drug Code Info20230503
Product NDC51655-383
Product NUIN0000175608 M0020795
Pharma Class (EPC)Sulfonylurea [EPC]
Pharma Class (CS)Sulfonylurea Compounds [CS]
Recall Initiation Date20230316
Report Date20230503
Classification Date20230426
Address4838 Fletcher Ave Ste 1000
Indianapolis, IN 46203-1642
United States
Recalling FirmNorthwind Pharmaceuticals LLC
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Unique Ingredient Identifier6KY687524K
Drug Application NumberANDA078181
Structured Product Labeling (SPL ID)f2f2d6da-eb41-4290-e053-2a95a90a6ca0
Structured Product Labeling (SPL Set ID)f2f2d6da-eb40-4290-e053-2a95a90a6ca0
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