Recall Enforment Report D-0383-2024

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Optikem International, Inc., originally initiated on 02-29-2024 for the product TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15. The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0383-2024	02-29-2024	03-20-2024	Class II	106,704 bottles	TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.	Lack of Assurance of Sterility	Ongoing
D-0377-2024	02-29-2024	03-20-2024	Class II	9,936 bottles	TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.	Lack of Assurance of Sterility	Ongoing
D-0382-2024	02-29-2024	03-20-2024	Class II	139,656 bottles	TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.	Lack of Assurance of Sterility	Ongoing
D-0375-2024	02-29-2024	03-20-2024	Class II	30,240 bottles	TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.	Lack of Assurance of Sterility	Ongoing
D-0376-2024	02-29-2024	03-20-2024	Class II	7,248 bottles	TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.	Lack of Assurance of Sterility	Ongoing
D-0379-2024	02-29-2024	03-20-2024	Class II	10,536 bottles	TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.	Lack of Assurance of Sterility	Ongoing
D-0381-2024	02-29-2024	03-20-2024	Class II	19,344 bottles	TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.	Lack of Assurance of Sterility	Ongoing
D-0384-2024	02-29-2024	03-20-2024	Class II	46,621 bottles	hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150	Lack of Assurance of Sterility	Ongoing
D-0380-2024	02-29-2024	03-20-2024	Class II	24,216 bottles	TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.	Lack of Assurance of Sterility	Ongoing
D-0378-2024	02-29-2024	03-20-2024	Class II	47,832 bottles	TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.	Lack of Assurance of Sterility	Ongoing

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
17312-002	Blur Relief	Jacobaea Maritima, Calcium Fluoride, Conium Maculatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, Sodium Chloride, Ruta Graveolens Flowering Top	Liquid	Intraocular	Trp Company	Human Otc Drug
17312-013	Pink Eye Relief	Aconitum Napellus - Apis Mellifera - Silver Nitrate - Euphrasia Stricta - Sodium Arsenate, Dibasic, Heptahydrate -	Liquid	Ophthalmic	Trp Company	Human Otc Drug
17312-027	Agingeye Relief	Tribasic Calcium Phosphate, Calendula Officinalis Flowering Top, Carbon Disulfide, Jacobaea Maritima, Conium Maculatum Flowering Top, Euphrasia Stricta, Selenium, Zinc	Liquid	Ophthalmic	Trp Company	Human Otc Drug
17312-032	Allergy Eyes Relief	Allium Cepa, Ambrosia, Apis, Euphrasia, Histamine Hydrochloricum, Sabadilla, Sulphur	Liquid	Ophthalmic	Trp Company	Human Otc Drug
17312-040	Eye Twitching Relief	Amanita Muscaria Fruiting Body, Copper, Euphrasia Stricta, Pilocarpus Jaborandii Whole, Magnesium Phosphate, Dibasic Trihydrate, Physostigma Venenosum Seed, Tin	Liquid	Ophthalmic	Trp Company	Human Otc Drug
17312-098	Floaters Relief	Chelidonium Majus, Physostigma Venenosum Seed, Euphrasia Stricta,potassium Sulfate, Sodium Chloride, Phosphorus, Silicon Dioxide, Sepia Officinalis Juice	Liquid	Ophthalmic	Trp Company	Human Otc Drug
17312-172	Eye Strain Relief	Aconitum Napellus - Apis Mellifera - Silver Nitrate - Euphrasia Stricta - Sodium Arsenate, Dibasic, Heptahydrate -	Liquid	Ophthalmic	Trp Company	Human Otc Drug
17312-178	Dryness Relief	Silver, Sodium Chloride, Nutmeg, Ruta Graveolens, Sulfur, Zinc	Liquid	Ophthalmic	Trp Company	Human Otc Drug

Field Name	Field Value
Event ID	94145 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0383-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product distributed Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	106,704 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-20-2024
Recall Initiation Date	02-29-2024 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Optikem International, Inc.
Code Info	Lot #: R608, Exp:04-21-2024, R609, Exp: 05-19-2024, R610, Exp: 07-28-2024, R611, Exp: 10-6-2024; R612, Exp: 02-02-2025, R613, Exp: 10-12-2025, R614, Exp: 11-02-2025 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Ongoing

Field Name	Field Value
Event ID	94145 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0377-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product distributed Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	9,936 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-20-2024
Recall Initiation Date	02-29-2024 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Optikem International, Inc.
Code Info	Lot #: C303, Exp: 07-27-2025 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	17312-040-15
Status	Ongoing

Field Name	Field Value
Event ID	94145 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0382-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product distributed Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	139,656 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-20-2024
Recall Initiation Date	02-29-2024 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Optikem International, Inc.
Code Info	Lot #: P516, Exp: 03-24-2024, P517, Exp: 08-31-2024, P518, Exp:10-20-2024, P519, Exp: 03-09-2025, P520, Exp: 10-19-2025, P521, Exp: 11-09-2025, P522, Exp: 11-16-2025, P523, Exp: 01-18-2026, P524, Exp: 04-26-2026, P525, Exp: 05-10-2026, P526, Exp: 06-07-2026 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	17312-013-15; 17312-013-99
Status	Ongoing

Field Name	Field Value
Event ID	94145 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0375-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product distributed Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	30,240 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-20-2024
Recall Initiation Date	02-29-2024 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Optikem International, Inc.
Code Info	Lot #: A703, Exp: 02-15-2026, A704, Exp: 03-22-2026, A705, Exp: 04-05-2026 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	17312-032-15; 17312-032-99
Status	Ongoing

Field Name	Field Value
Event ID	94145 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0376-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product distributed Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	7,248 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-20-2024
Recall Initiation Date	02-29-2024 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Optikem International, Inc.
Code Info	Lot #: B905, Exp: 07-13-2025 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	17312-002-11
Status	Ongoing

Field Name	Field Value
Event ID	94145 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0379-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product distributed Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	10,536 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-20-2024
Recall Initiation Date	02-29-2024 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Optikem International, Inc.
Code Info	Lot #: E206, Exp: 09-21-2025 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	17312-172-15
Status	Ongoing

Field Name	Field Value
Event ID	94145 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0381-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product distributed Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	19,344 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-20-2024
Recall Initiation Date	02-29-2024 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Optikem International, Inc.
Code Info	Lot #: G806, Exp: 06-01-2025, G807, Exp: 10-27-2026. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	17312-027-15
Status	Ongoing

Field Name	Field Value
Event ID	94145 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0384-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product distributed Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	46,621 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-20-2024
Recall Initiation Date	02-29-2024 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Optikem International, Inc.
Code Info	All lots within Expiry Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Ongoing

Field Name	Field Value
Event ID	94145 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0380-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product distributed Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	24,216 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-20-2024
Recall Initiation Date	02-29-2024 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Optikem International, Inc.
Code Info	Lot #: F404, Exp: 05-14-2025, F405, Exp: 08-24-2025, F406, Exp: 10-11-2026. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	17312-098-15
Status	Ongoing

Field Name	Field Value
Event ID	94145 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0378-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product distributed Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	47,832 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-20-2024
Recall Initiation Date	02-29-2024 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Optikem International, Inc.
Code Info	Lot #: D101, Exp: 07-01-2024, D102, Exp: 12-01-2024, D103, Ep: 04-13-2025 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	17312-178-15; 17312-178-99
Status	Ongoing