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Altaire Pharmaceuticals, Inc.

FDA Regulatory Profile

Altaire Pharmaceuticals, Inc. appears in FDA public data with 135 recalls — including 1 Class I (most serious) —, 1 510(k) clearance, 14 FDA inspections, and 2 compliance actions on record. Its most recent recall (D-0474-2020, Class II) was initiated on July 2, 2019. Its most recent 510(k) clearance was granted on April 25, 2007.

Summary

Total Recalls
135 (1 Class I)
510(k) Clearances
1
Inspections
14
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-0454-2020Class IICVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, DisJuly 2, 2019
D-0395-2020Class IICVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS PJuly 2, 2019
D-0404-2020Class IICVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: July 2, 2019
D-0471-2020Class IITRP Pink Eye Relief, 10 mL, NDC 17312-013-15July 2, 2019
D-0439-2020Class IIActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, Manufactured by: AltaireJuly 2, 2019
D-0482-2020Class IIOCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77July 2, 2019
D-0427-2020Class IIiSolutions NanoTears HA Preservative Free Multi - Dose Lubricant Gel Drops Sterile, 0.33 FL OZ (10 mJuly 2, 2019
D-0364-2020Class IIEquate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Package Size: 2 x 15 mL, July 2, 2019
D-0462-2020Class IINatural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL, NDC 68770-143-15July 2, 2019
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-0483-2020Class IIFreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15July 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-0425-2020Class IIAltaire Sterile Eye Wash, 118 mL (4 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 5July 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-0430-2020Class IIiSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry EJuly 2, 2019

Recent 510(k) Clearances

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

FDA data resources