TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP...

FDA Drug Recall #D-0377-2024 — Class II — February 29, 2024

Recall Summary

Recall Number D-0377-2024
Classification Class II — Moderate risk
Date Initiated February 29, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Optikem International, Inc.
Location Denver, CO
Product Type Drugs
Quantity 9,936 bottles

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

Distribution Pattern

Product distributed Nationwide in the USA

Lot / Code Information

Lot #: C303, Exp: 07-27-2025

Other Recalls from Optikem International, Inc.

Recall # Classification Product Date
D-0380-2024 Class II TRP Natural Eyes Floaters Relief, Sterile Eye D... Feb 29, 2024
D-0375-2024 Class II TRP Natural Eyes Allergy Eyes Relief, Sterile E... Feb 29, 2024
D-0381-2024 Class II TRP Natural Eyes Aging Eye Relief, Sterile Eye ... Feb 29, 2024
D-0379-2024 Class II TRP Eye strain Relief, Sterile Eye Drops, Homeo... Feb 29, 2024
D-0383-2024 Class II TRP Natural Eyes Red Eye Relief, Sterile Eye Dr... Feb 29, 2024

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.