Gabapentin Capsule
FDA Recall NDC 45963-556
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Gabapentin (NDC 45963-556). A significant event, classified as Class II, was initiated on Dec 15, 2014 by Actavis Pharma, Inc.. 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
10,857 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, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, 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.
Batch or Lot Expiration Information
Lot# s: a) G01889A2 Exp 06/2015, b) G01942A1 Exp 08/2015
Affected Packages Involved in this Recall
45963-555-11Product
45963-555-50Product
45963-556-11Product
45963-556-50Product
45963-557-11Product
45963-557-50Product
14550-513-02Product
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
29,622 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, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, 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.
Batch or Lot Expiration Information
Lot# s: a) G01966A1, Exp 10/2015, b) G02004A1, Exp 03/2016
Affected Packages Involved in this Recall
45963-555-11Product
45963-555-50Product
45963-556-11Product
45963-556-50Product
45963-557-11Product
45963-557-50Product
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.
