D-1158-2023 Class II Ongoing

Recalled by AMMAN PHARMACEUTICAL INDUSTRIES — Amman

FDA drug recall D-1158-2023 was initiated by AMMAN PHARMACEUTICAL INDUSTRIES on Sep 1, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 16,500 units.

Recall Details

Product Type
Drugs
Report Date
Sep 27, 2023
Initiation Date
Sep 1, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,500 units

Product Description

TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-165-13.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

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

Code Information

Lot: 180001 EXP: 01/25

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1158-2023
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-1158-2023. Report a data issue: hello@regdatalab.com.