Drug product
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
D-0337-2015
Product summary
- Event
- Event 70001
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24,240 Bottles
- Official record key
drug-enforcement:D-0337-2015
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: G01960A1, Exp 09/2015, G01967A1, Exp 10/2015
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.