Drug recall D-0338-2015
Product
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.
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.
Lots and codes
Lot #s: a) G01966A1, Exp 10/2015, b) G02004A1, Exp 03/2016
Recall details
- Recalling firm
- Actavis Elizabeth LLC, Elizabeth, NJ
- Quantity
- 29,622 Bottles
- Distribution
- Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 15, 2014
- Terminated
- November 20, 2015
Related products
- Gabapentin – drug information
- NDC 45963-556 Gabapentin · Gabapentin 300 mg/1 · Actavis Pharma, Inc.
- NDC 45963-557 Gabapentin · Gabapentin 400 mg/1 · Actavis Pharma, Inc.
- NDC 45963-555 Gabapentin · Gabapentin 100 mg/1 · Actavis Pharma, Inc.