Home / Recalls / Actavis Elizabeth LLC / D-0338-2015

D-0338-2015 Class II Terminated

Recalled by Actavis Elizabeth LLC — Elizabeth, NJ

Recall Details

Product Type
Drugs
Report Date
January 14, 2015
Initiation Date
December 15, 2014
Termination Date
November 20, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29,622 Bottles

Product Description

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.

Distribution Pattern

Puerto Rico

Code Information

Lot #s: a) G01966A1, Exp 10/2015, b) G02004A1, Exp 03/2016

Other recalls by Actavis Elizabeth LLC

  • D-0143-2017 Class III — NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and dist (October 6, 2016)
  • D-0816-2016 Class II — Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, (February 16, 2016)
  • D-0815-2016 Class II — Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, (February 16, 2016)
  • D-0814-2016 Class II — Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, (February 16, 2016)
  • D-0813-2016 Class II — Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, (February 16, 2016)
  • D-0395-2015 Class II — Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx (February 10, 2015)
  • D-0337-2015 Class II — Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured (December 15, 2014)
  • D-0336-2015 Class II — Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550 (December 15, 2014)
  • D-1153-2014 Class II — Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: (February 10, 2014)
  • D-1091-2014 Class II — Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx (February 4, 2014)