Home / Companies / Kilitch Healthcare India Limited

Kilitch Healthcare India Limited

FDA Regulatory Profile

Summary

Total Recalls
22 (22 Class I)
510(k) Clearances
0
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0309-2024Class ILubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack),November 13, 2023
D-0300-2024Class ITarget brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.November 13, 2023
D-0310-2024Class IRugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FNovember 13, 2023
D-0290-2024Class ICVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ November 13, 2023
D-0296-2024Class ICVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) November 13, 2023
D-0294-2024Class ICVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), pacNovember 13, 2023
D-0298-2024Class ICVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (1November 13, 2023
D-0311-2024Class IUp&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles November 13, 2023
D-0306-2024Class ILubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, DisNovember 13, 2023
D-0303-2024Class IEQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3November 13, 2023
D-0302-2024Class IVelocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles November 13, 2023
D-0308-2024Class IMulti-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.November 13, 2023
D-0304-2024Class ILUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin PaNovember 13, 2023
D-0307-2024Class ILubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (1November 13, 2023
D-0301-2024Class ILeader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bNovember 13, 2023
D-0292-2024Class ICVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottlNovember 13, 2023
D-0305-2024Class ICVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FNovember 13, 2023
D-0293-2024Class IRugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, DisNovember 13, 2023
D-0295-2024Class ILeader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.3November 13, 2023
D-0291-2024Class ILeader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mNovember 13, 2023