Product Safety Recalls

Product Recall Tracker

GABAPENTIN Recall D-0570-2023

Description: Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61

GABAPENTIN Recall D-0570-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0570-2023
Event ID92174
Active SubstanceGABAPENTIN
Drug RouteORAL
DistributionUSA Nationwide
Quantity3984 cartons
Recall ReasonProduct mixup: one foreign tablet found in product.
Drug ClassificationClass III
Drug Code Info20230517
Product NDC0904-6823 0904-7108
Product NUIN0000008486
Pharma Class (PE)Decreased Central Nervous System Disorganized Electrical Activity [PE]
Recall Initiation Date20230424
Report Date20230517
Classification Date20230510
Address341 Mason Rd
La Vergne, TN 37086-3606
United States
Recalling FirmThe Harvard Drug Group
Initial Notification Letter
Unique Ingredient Identifier6CW7F3G59X
Drug Application NumberANDA200651
Structured Product Labeling (SPL ID)e4dba0e2-e43e-4334-83e7-3db4fcd7f659
Structured Product Labeling (SPL Set ID)152adf1d-ec0c-4561-bf80-e4c7da158723
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