Gabapentin Tablet
FDA Recall NDC 50228-178
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Gabapentin (NDC 50228-178). A significant event, classified as Class III, was initiated on Feb 17, 2023 by Sciegen Pharmaceuticals, Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Feb 17, 2023
Mar 08, 2023
4,392 bottles
Recall Profile & Regulatory Data
Event ID
91717
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sciegen Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Jun 17, 2024
Product Description
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.
Batch or Lot Expiration Information
Lot# G177092, Exp. 11/24
Affected Packages Involved in this Recall
50228-177-30Product
50228-177-01Product
50228-177-05Product
50228-178-30Product
50228-178-01Product
50228-178-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
