Home / Recalls / Actavis Elizabeth LLC / D-0814-2016

D-0814-2016 Class II Terminated

Recalled by Actavis Elizabeth LLC — Elizabeth, NJ

Recall Details

Product Type
Drugs
Report Date
April 13, 2016
Initiation Date
February 16, 2016
Termination Date
September 22, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
257,746 Bottles

Product Description

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-748-11.

Reason for Recall

Failed Impurities/Degradation Specifications: Out of specification for impurities.

Distribution Pattern

US: Nationwide

Code Information

Lot #: 3992J141, Expiry: 5/16; Lot #: 3993J142, Expiry: 5/16; Lot #: 0695B151, Expiry: 7/16; Lot #: 0696B151, Expiry: 7/16; Lot #: 0378A151, Expiry: 7/16; Lot #: 0379A151, Expiry: 7/16; Lot #: 0697B151, Expiry: 8/16; Lot #: 2427F151, Expiry: 11/16; Lot #: 1947E151, Expiry: 11/16; Lot #: 1330C151, Expiry: 11/16; Lot #: 1331C151, Expiry: 11/16; Lot #: 1946E151, Expiry: 11/16; Lot #: 3652H151, Expiry: 2/17; Lot #: 3653H151, Expiry: 3/17, Lot #: 3654H151, Expiry: 3/17; Lot #: 4251K151, Expiry: 3/17; Lot #: 4250K151, Expiry: 4/17; Lot #: 4252K151, Expiry: 4/17; Lot #: 4249K151, Expiry: 4/17; Lot #: 5101M151, Expiry: 5/17.

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-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)
  • D-1091-2014 Class II — Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx (February 4, 2014)