Home / Recalls / Altaire Pharmaceuticals, Inc. / D-0483-2020

D-0483-2020 Class II

Recalled by Altaire Pharmaceuticals, Inc. — Aquebogue, NY

Recall Details

Product Type
Drugs
Report Date
November 27, 2019
Initiation Date
July 2, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
31070 units

Product Description

FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot #: 18095, Exp 4/20

Other recalls by Altaire Pharmaceuticals, Inc.

  • D-0379-2020 Class II — CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium (July 2, 2019)
  • D-0430-2020 Class II — iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free M (July 2, 2019)
  • D-0455-2020 Class II — Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL (July 2, 2019)
  • D-0474-2020 Class II — Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, (July 2, 2019)
  • D-0411-2020 Class II — CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. (July 2, 2019)
  • D-0451-2020 Class II — OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufact (July 2, 2019)
  • D-0358-2020 Class II — Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net (July 2, 2019)
  • D-0422-2020 Class II — Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, (July 2, 2019)
  • D-0448-2020 Class II — OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, I (July 2, 2019)
  • D-0389-2020 Class II — CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium (July 2, 2019)