Home / Recalls / Altaire Pharmaceuticals, Inc. / D-0397-2020

D-0397-2020 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
N/A

Product Description

Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-503-15

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

16260 9/19 17303 10/20 18032 2/21 18235 9/21 18285 11/21 19021 1/22

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  • D-0444-2020 Class II — OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, (July 2, 2019)
  • D-0402-2020 Class II — CVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ (15 mL), Distri (July 2, 2019)
  • D-0469-2020 Class II — TRP Blur Relief, 15 mL, NDC 17312-002-11 (July 2, 2019)
  • D-0379-2020 Class II — CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium (July 2, 2019)
  • D-0464-2020 Class II — Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15 (July 2, 2019)
  • D-0483-2020 Class II — FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15 (July 2, 2019)
  • D-0411-2020 Class II — CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. (July 2, 2019)