Status
Ongoing
Drug Enforcement D-1157-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
September 27, 2023
Termination Date
—
Product Information
- Product description
- TRP Natural Eyes, Eye Lid 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: 17312-417-19.
- Product quantity
- 8,000 units
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to two (2) direct accounts in RI and CO.
Location & Firm
- Recalling firm
- AMMAN PHARMACEUTICAL INDUSTRIES
- Address
-
Building 108, Street A3, King Abdullah Ii Industrial City
Jordan - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1157-2023
- Event ID
- 92974
- Recall initiation date
- September 1, 2023
- Center classification date
- September 15, 2023
- Code info
- Lot: FV005 EXP:03/25
- More code info
- —