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-0474-2020Class IIPuralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20July 2, 2019
D-0483-2020Class IIFreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15July 2, 2019
D-0459-2020Class IIGrandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dist. By Grandall DistrJuly 2, 2019
D-0363-2020Class IIWalgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /Eye Lubricant, Net Wt. July 2, 2019
D-0366-2020Class IIEquate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, DistrJuly 2, 2019
D-0409-2020Class IICVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Twin Pack, Item#: 495323, Product Size: 2 x 1July 2, 2019
D-0490-2020Class IIClear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92554-70103-7July 2, 2019
D-0471-2020Class IITRP Pink Eye Relief, 10 mL, NDC 17312-013-15July 2, 2019
D-0463-2020Class IINatural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15July 2, 2019
D-0402-2020Class IICVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ (15 mL), Distributed by: CVS PharmaJuly 2, 2019
D-0482-2020Class IIOCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77July 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-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

Recent 510(k) Clearances

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