Gabapentin Capsule
FDA Recall NDC 16714-663
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 16714-663). A significant event, classified as Class II, was initiated on Oct 17, 2014 by Northstar Rx Llc. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Complaints of empty capsules received."
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
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Oct 17, 2014
Jan 14, 2015
24,816 bottles
Recall Profile & Regulatory Data
Event ID
69807
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 23, 2016
Product Description
Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16714-662-01, UPC 3 16714-662-01 5.
Batch or Lot Expiration Information
Lot# : GESB14011-A, Exp 12/15
Affected Packages Involved in this Recall
16714-661-01Product
16714-661-02Product
16714-661-03Product
16714-662-01Product
16714-662-02Product
16714-662-03Product
16714-663-01Product
16714-663-02Product
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.
