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Class II: temporary or reversible health riskOngoing

Optikem International TRP Natural Eyes Floaters Relief Recall

TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0

Optikem International, Inc. · Denver, CO

Risk level
Class II
Reported by FDA
Mar 20, 2024
Recall ID
D-0380-2024
Check your lot numberHow we source this data

Summary

Optikem International recalled TRP Natural Eyes Floaters Relief starting Feb 29, 2024. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0380-2024 on Mar 20, 2024. Reason: Lack of Assurance of Sterility. Status: Ongoing.

Why it was recalled

Lack of Assurance of Sterility

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.

Lot numbers, UPCs & expiration codes

Lot #: F404, Exp: 05-14-2025, F405, Exp: 08-24-2025, F406, Exp: 10-11-2026.

Where it was sold

Product distributed Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0380-2024
Classification
Class II
Status
Ongoing
Recall initiated
Feb 29, 2024
FDA report date
Mar 20, 2024
Quantity
24,216 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Optikem International, Inc.

Original FDA data

Every field from FDA enforcement report D-0380-2024, exactly as published.

Show all FDA fields
City
Denver
State
CO
Status
Ongoing
Country
United States
Event ID
94145
Address
2172 S Jason St
Code information
Lot #: F404, Exp: 05-14-2025, F405, Exp: 08-24-2025, F406, Exp: 10-11-2026.
Postal code
80223-4005
Report date
Mar 20, 2024
Product type
Drugs
Recall number
D-0380-2024
Classification
Class II
Recalling firm
Optikem International, Inc.
Product quantity
24,216 bottles
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Product distributed Nationwide in the USA
Recall initiation date
Feb 29, 2024
Initial firm notification
Letter
Center classification date
Mar 12, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0380-2024, published Mar 20, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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