Optikem International, Inc.

FDA Regulatory Profile

Summary

Total Recalls
10
510(k) Clearances
2
Inspections
5
Compliance Actions
3

Recent Recalls

NumberClassProductDate
D-0382-2024Class IITRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured fFebruary 29, 2024
D-0375-2024Class IITRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), ManufacturedFebruary 29, 2024
D-0376-2024Class IITRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc,February 29, 2024
D-0377-2024Class IITRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP CoFebruary 29, 2024
D-0379-2024Class IITRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP CompFebruary 29, 2024
D-0381-2024Class IITRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured February 29, 2024
D-0384-2024Class IIhyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hFebruary 29, 2024
D-0383-2024Class IITRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured foFebruary 29, 2024
D-0380-2024Class IITRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP CompanFebruary 29, 2024
D-0378-2024Class IITRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP CompanyFebruary 29, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K071203SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSESJune 13, 2007
K822495LE CASE HARD CONTACT LENS STORAGE CASESeptember 30, 1982