Home / Recalls / Actavis Inc / D-1471-2016

D-1471-2016 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
672 bottles

Product Description

Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82

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

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  • D-1472-2016 Class III — Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed (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)
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  • D-0232-2015 Class II — Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, M (August 25, 2014)