Gabapentin Capsule
FDA Recall NDC 65862-199
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 65862-199). A significant event, classified as Class II, was initiated on Mar 18, 2020 by Aurobindo Pharma Limited. The reported reason for this action was: "CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed"
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 II Terminated
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Mar 18, 2020
Apr 22, 2020
26625 units
Recall Profile & Regulatory Data
Event ID
85183
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Mar 25, 2024
Product Description
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
Batch or Lot Expiration Information
Lot# : 198180048A, Exp. Date 04/2021; 198180061A, Exp. Date 06/2020; 19819017A1, Exp. Date 02/2021
Affected Packages Involved in this Recall
65862-198-01Product
65862-198-05Product
65862-198-99Product
65862-198-10Product
65862-198-90Product
65862-198-18Product
65862-198-27Product
65862-199-01Product
65862-199-05Product
65862-199-99Product
65862-199-10Product
65862-199-30Product
65862-199-60Product
65862-199-90Product
65862-199-18Product
65862-199-27Product
65862-200-01Product
65862-200-05Product
65862-200-10Product
65862-200-90Product
65862-200-27Product
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.
