PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 14, 2015 Initiated: December 15, 2014 #D-0337-2015

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

Reason for Recall

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.

Details

Recalling Firm
Actavis Elizabeth LLC
Units Affected
24,240 Bottles
Distribution
Puerto Rico
Location
Elizabeth, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Actavis Elizabeth LLC. Units affected: 24,240 Bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 14, 2015. Severity: Moderate. Recall number: D-0337-2015.