drugs Class II Updated 2015-01-14

Actavis Elizabeth LLC recalls Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules p

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Puerto Rico
Lot/Code Info: Lot #s: a) G01889A2 Exp 06/2015, b) G01942A1 Exp 08/2015
View official government recall

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