Home / Recalls / Actavis Inc / D-0439-2017

D-0439-2017 Class III Terminated

Recalled by Actavis Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
February 1, 2017
Initiation Date
January 12, 2017
Termination Date
March 5, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
164,844 units

Product Description

Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53

Reason for Recall

Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.

Distribution Pattern

Nationwide in the US

Code Information

Lot #: GA51265, Ex[p. Jan-2017, GA51454, GA51553, GA51583, Exp. Feb-2017, GA51598, GA51724, GA51725, GA51749, Exp. Mar-2017

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  • D-1471-2016 Class III — Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL (August 2, 2016)
  • D-1448-2016 Class II — Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, R (July 11, 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-0396-2015 Class II — Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx On (February 12, 2015)
  • D-0406-2015 Class II — Vancomycin Hydrochloride Capsules, USP, 250 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)