Home / Recalls / Altaire Pharmaceuticals, Inc. / D-0440-2020

D-0440-2020 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
81403 units

Product Description

OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

17186 6/20 17345 11/20 19010 1/22 17041 2/2020 16217 8/19

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)