Altaire Pharmaceuticals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
135 (1 Class I)
510(k) Clearances
1
Inspections
13
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0379-2020Class IICVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) July 2, 2019
D-0464-2020Class IINatural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15July 2, 2019
D-0411-2020Class IICVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Item #July 2, 2019
D-0436-2020Class IIOfloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-14July 2, 2019
D-0422-2020Class IIAltaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mJuly 2, 2019
D-0447-2020Class IIOCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for OCuSOFT, Inc.July 2, 2019
D-0468-2020Class IITRP/ TARGET up & up intensive relief lubricating eye drop, 10 mLJuly 2, 2019
D-0407-2020Class IICVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief, Sterile, 0.33 fl. oz.July 2, 2019
D-0423-2020Class IIAltaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC July 2, 2019
D-0455-2020Class IIAltaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL, Sterile, Rx only, July 2, 2019
D-0474-2020Class IIPuralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20July 2, 2019
D-0451-2020Class IIOCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT IncJuly 2, 2019
D-0358-2020Class IIPuralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net Wt. 1 g (NDC 0574-40July 2, 2019
D-0448-2020Class IIOCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406July 2, 2019
D-0438-2020Class IIActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF Sterile, 0.25 FL OZ (7.5 mL), MaJuly 2, 2019
D-0389-2020Class IICVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive SolJuly 2, 2019
D-0429-2020Class IIiSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, Mfd. By: by Altaire PharJuly 2, 2019
D-0391-2020Class IICVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5% Glycerin 1% PolJuly 2, 2019
D-0454-2020Class IICVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, DisJuly 2, 2019
D-0374-2020Class IICVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15 mL), Item #31July 2, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K062332ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTIONApril 25, 2007