FDAFDA · Food and drugs·Recall number D-0336-2015
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.
Published January 14, 2015 · Recall initiated: December 15, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- GABAPENTIN
- Manufacturer
- Actavis Elizabeth LLC
- Distributor
- Puerto Rico
- UPC
- 0345963555113
- Lot
- Lot #s: a) G01889A2 Exp 06/2015, b) G01942A1 Exp 08/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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