Drug 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.
D-0336-2015
Product summary
- Event
- Event 70001
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,857 Bottles
- Official record key
drug-enforcement:D-0336-2015
Official wording
Reason: 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.
Code information: Lot #s: a) G01889A2 Exp 06/2015, b) G01942A1 Exp 08/2015
Distribution pattern: Puerto Rico
Derived failure modes
-
Unknown
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.