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-0430-2020Class IIiSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry EJuly 2, 2019
D-0455-2020Class IIAltaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL, Sterile, Rx only, July 2, 2019
D-0483-2020Class IIFreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15July 2, 2019
D-0474-2020Class IIPuralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20July 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-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-0422-2020Class IIAltaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mJuly 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-0389-2020Class IICVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive SolJuly 2, 2019
D-0468-2020Class IITRP/ TARGET up & up intensive relief lubricating eye drop, 10 mLJuly 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-0359-2020Class IILubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubricant), 0.5 oz. (15 mL),July 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-0454-2020Class IICVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, DisJuly 2, 2019
D-0417-2020Class IIActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals Inc., AqueJuly 2, 2019
D-0375-2020Class IICVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 1 fl. oz., (30 mL), DistributJuly 2, 2019
D-0461-2020Class IIAltaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire PharmaceuticJuly 2, 2019
D-0432-2020Class IINano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct., July 2, 2019

Recent 510(k) Clearances

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