Home / Recalls / Actavis Elizabeth LLC / D-190-2013

D-190-2013 Class III Terminated

Recalled by Actavis Elizabeth LLC — Elizabeth, NJ

Recall Details

Product Type
Drugs
Report Date
March 13, 2013
Initiation Date
February 13, 2013
Termination Date
March 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,264 Bottles

Product Description

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.

Reason for Recall

Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.

Distribution Pattern

Nationwide

Code Information

Lot #: 50077231

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-0338-2015 Class II — Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963 (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)