Home / Recalls / Altaire Pharmaceuticals, Inc. / D-0441-2020

D-0441-2020 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
88,008 units

Product Description

Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

17205 7/19 17206 7/19 18003 1/20 18097 4/20 18166 7/20 18292 11/20 19106 4/21

Other recalls by Altaire Pharmaceuticals, Inc.

  • D-0472-2020 Class II — Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size (July 2, 2019)
  • D-0459-2020 Class II — Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dis (July 2, 2019)
  • D-0482-2020 Class II — OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77 (July 2, 2019)
  • 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)