Multi event Drug Recall Enforcement Report Class II voluntary initiated by Actavis Elizabeth LLC, originally initiated on 12-15-2014 for the 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 The product was recalled due to 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.. The product was distributed in Puerto Rico and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0337-2015 | 12-15-2014 | 01-14-2015 | Class II | 24,240 Bottles | 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 | 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. | Terminated |
| D-0338-2015 | 12-15-2014 | 01-14-2015 | Class II | 29,622 Bottles | 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. | 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. | Terminated |
| D-0336-2015 | 12-15-2014 | 01-14-2015 | Class II | 10,857 Bottles | 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. | 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. | Terminated |
Recalled Products
