Altaire Pharmaceuticals announced the voluntary recall of multiple ophthalmic prescription and over-the-counter drug products sold by OCuSOFT. The specific products include:
- OCuSOFT Homatropine Hydrobromide Ophthalmic Solution 5%; NDC# 54799-431-05; Product Size: 5mL
- OCuSOFT Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%; NDC# 54799-502-15; Product Size: 15mL
- OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution; NDC# 54799-503-15; Product Size: 15mL
- OCuSOFT Tetravisc Forte; NDC# 54799-504-01; Product Size: 0.6mL x 12 pcs; NDC# 54799-504-05 Product Size: 5mL
- OCuSOFT Tetravisc; NDC#: 54799-505-01; Product Size: 0.6mL x 12 pcs; NDC# 54799-505-05; Product Size: 5mL
- OCuSOFT Flucaine; NDC#: 54799-507-21; Product Size: 5mL
- OCuSOFT Eye Wash; NDC#: 54799-565-01; Product Size: 1oz; NDC# 54799-565-59; Product Size: 4oz
- OCuSOFT Tears Again Lubricant Eye Drops; NDC#: 54799-904-15; Product Size: 15mL; NDC# 54799-904-30; Product Size: 30mL
- OCuSOFT Tears Again Lubricant Eye Ointment Nighttime Relief; NDC#: 54799-906-35; Product Size: 3.5g
- OCuSOFT retaine NaCl Ophthalmic Ointment; SKU# 777-3-76; Product Size: 3.5g
- OCuSOFT retaine NaCl Ophthalmic Solution; SKU# 777-3-77; Product Size: 15mL
The specified lots, within expiry, distributed during the time period for the recalled products can be found here.
According to Altaire, no reports of adverse events or out of specifications results, including in-house and third party sterility testing, have been received at this time. The Company is initiating the recall as a precautionary measure due to concerns over the sufficiency of Quality Assurance controls in the manufacturing facility. The recall is being carried out to the retail level and is only for the specific lots mentioned.
The products are manufactured and labeled exclusively for OCuSOFT. Altaire has notified OCuSOFT of the impacted products and has requested OCuSOFT to perform a subrecall.
For more information regarding this recall contact Altaire Pharmaceuticals, by calling 1-800-258-2471 or email [email protected]