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Recall Observatory FDA recall evidence

Drug 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.

D-0383-2024

February 29, 2024

Class II

Product summary

Firm
Optikem International, Inc.
Event
Event 94145
Status
Ongoing
Classification
Class II
Quantity
106,704 bottles
Official record key
drug-enforcement:D-0383-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: 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

Distribution pattern: Product distributed Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility