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Recall Observatory FDA recall evidence

Drug product

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.

D-0379-2024

February 29, 2024

Class II

Product summary

Firm
Optikem International, Inc.
Event
Event 94145
Status
Ongoing
Classification
Class II
Quantity
10,536 bottles
Official record key
drug-enforcement:D-0379-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: E206, Exp: 09-21-2025

Distribution pattern: Product distributed Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility