FDA recall record

AMMAN PHARMACEUTICAL INDUSTRIES TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops recall — FDA D-1153-2023

Lack of Assurance of Sterility

Class IIclassification
D-1153-2023official record ID
Sep 27, 2023report date

Recall record at a glance

Official recordD-1153-2023
CategoryDrug Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmAMMAN PHARMACEUTICAL INDUSTRIES
Report dateSep 27, 2023
Recall initiation dateSep 1, 2023
Quantity8,810 units
LocationAmman, Jordan

Official product description

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.

Why the product was recalled

Lack of Assurance of Sterility

Distribution information

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

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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