Gaba 300-ezs Kit
FDA Recall NDC 59088-725
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 Gaba 300-ezs (NDC 59088-725). A significant event, classified as Class II, was initiated on Dec 15, 2014 by Puretek Corporation. The reported reason for this action was: "Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center."
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 Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Dec 15, 2014
Jan 14, 2015
24,240 Bottles
Recall Profile & Regulatory Data
Event ID
70001
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Actavis Elizabeth LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Puerto Rico
Termination Date
Nov 20, 2015
Product Description
Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11
Batch or Lot Expiration Information
Lot# s: G01960A1, Exp 09/2015, G01967A1, Exp 10/2015
Affected Packages Involved in this Recall
59088-725-00Product
45963-556-11Product
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.
