Home / Recalls / Actavis Inc / D-1472-2016

D-1472-2016 Class III Terminated

Recalled by Actavis Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
August 31, 2016
Initiation Date
August 2, 2016
Termination Date
February 8, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2543 bottles

Product Description

Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61

Reason for Recall

Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).

Distribution Pattern

Nationwide and Puerto Rico

Code Information

L503092, Exp 04/2016

Other recalls by Actavis Inc

  • D-0514-2017 Class III — Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx On (February 7, 2017)
  • D-0476-2017 Class II — Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactu (January 30, 2017)
  • D-0439-2017 Class III — Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, (January 12, 2017)
  • 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-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-0232-2015 Class II — Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, M (August 25, 2014)