Product Safety Recalls

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GLIMEPIRIDE Recall D-0527-2023

Description: Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9

GLIMEPIRIDE Recall D-0527-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0527-2023
Event ID91952
Active SubstanceGLIMEPIRIDE
Drug RouteORAL
DistributionUSA Nationwide
Quantity15 Bottles
Recall ReasoncGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Drug ClassificationClass II
Drug Code Info20230412
Product NDC68788-8066
Product NUIN0000175608 M0020795
Pharma Class (EPC)Sulfonylurea [EPC]
Pharma Class (CS)Sulfonylurea Compounds [CS]
Recall Initiation Date20230323
Report Date20230412
Classification Date20230406
Address1250 N Lakeview Ave Ste O
Anaheim, CA 92807-1801
United States
Recalling FirmPreferred Pharmaceuticals, Inc.
Initial Notification Letter
Unique Ingredient Identifier6KY687524K
Drug Application NumberANDA078181
Structured Product Labeling (SPL ID)9daf0202-6c94-4b42-9bc6-3e473c771b63
Structured Product Labeling (SPL Set ID)fc359d31-ef3d-4d6f-bd5a-8636f8211aea
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