Home / Recalls / Actavis Inc / D-1448-2016

D-1448-2016 Class II Terminated

Recalled by Actavis Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
August 3, 2016
Initiation Date
July 11, 2016
Termination Date
February 16, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,062 units

Product Description

Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Nationwide

Code Information

Lot #: 3803J141, Exp. 7/2016

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  • D-0439-2017 Class III — Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, (January 12, 2017)
  • D-1472-2016 Class III — Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed (August 2, 2016)
  • D-1471-2016 Class III — Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL (August 2, 2016)
  • D-1457-2016 Class II — Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufacture (June 30, 2016)
  • D-1148-2015 Class III — Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day (June 4, 2015)
  • D-0406-2015 Class II — Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx On (February 12, 2015)
  • D-0396-2015 Class II — Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx On (February 12, 2015)
  • D-0233-2015 Class II — Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, M (August 25, 2014)