FDAFDA · Food and drugs·Recall number D-0337-2015
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
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
- GABA 300-EZS
- Manufacturer
- Actavis Elizabeth LLC
- Distributor
- Puerto Rico
- UPC
- 0731477272217
- Lot
- Lot #s: G01960A1, Exp 09/2015, G01967A1, Exp 10/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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