D-1164-2023 Class II Ongoing
FDA drug recall D-1164-2023 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: 196,442 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 27, 2023
- Initiation Date
- Sep 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 196,442 units
Product Description
TRP Natural Eyes, Red Eye 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: 17312-095-19.
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: IW001 EXP:07/24; Lot: IW002 EXP: 12/24
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1164-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026