Drug recall D-0337-2015
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
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: G01960A1, Exp 09/2015, G01967A1, Exp 10/2015
Recall details
- Recalling firm
- Actavis Elizabeth LLC, Elizabeth, NJ
- Quantity
- 24,240 Bottles
- Distribution
- Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 15, 2014
- Terminated
- November 20, 2015
Related products
- Gaba 300-EZS – drug information
- NDC 45963-556 Gabapentin · Gabapentin 300 mg/1 · Actavis Pharma, Inc.
- NDC 59088-725 Gaba 300-EZS · · PureTek Corporation