Gabapentin Tablet, Film Coated
FDA Recall NDC 76282-405
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 76282-405). A significant event, classified as Class III, was initiated on May 14, 2020 by Exelan Pharmaceuticals Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing."
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
May 2020 Class III Recall: Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
May 14, 2020
May 27, 2020
2,202 bottles
Recall Profile & Regulatory Data
Event ID
85646
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Aug 31, 2020
Product Description
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.
Batch or Lot Expiration Information
Lot# NB900413, Exp. 12/2020
Affected Packages Involved in this Recall
76282-405-30Product
76282-405-90Product
76282-405-01Product
76282-405-05Product
76282-406-30Product
76282-406-90Product
76282-406-01Product
76282-406-05Product
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.
