Home / Recalls / Actavis Inc / D-0514-2017

D-0514-2017 Class III Terminated

Recalled by Actavis Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
March 15, 2017
Initiation Date
February 7, 2017
Termination Date
January 9, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14280 bottles

Product Description

Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05

Reason for Recall

Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.

Distribution Pattern

Nationwide

Code Information

Lot # 348748, Exp 11/30/2017; 350578, Exp 3/31/2018; 633467, Exp 3/31/2017

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-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)