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Recall Observatory FDA recall evidence

Drug product

TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-097-19.

D-1153-2023

September 01, 2023

Class II

Product summary

Firm
AMMAN PHARMACEUTICAL INDUSTRIES
Event
Event 92974
Status
Ongoing
Classification
Class II
Quantity
8,810 units
Official record key
drug-enforcement:D-1153-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: FT001; EXP: 07/24

Distribution pattern: Product was distributed to two (2) direct accounts in RI and CO.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility