Why it was recalled
Lack of Assurance of Sterility
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.
Lot numbers, UPCs & expiration codes
Lot: FT001; EXP: 07/24
Where it was sold
Product was distributed to two (2) direct accounts in RI and CO.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1153-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 1, 2023
- FDA report date
- Sep 27, 2023
- Quantity
- 8,810 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AMMAN PHARMACEUTICAL INDUSTRIES
Original FDA data
Every field from FDA enforcement report D-1153-2023, exactly as published.
Show all FDA fields
- City
- Amman
- Status
- Ongoing
- Country
- Jordan
- Event ID
- 92974
- Address
- Building 108
- Address (line 2)
- Street A3, King Abdullah Ii Industrial City
- Code information
- Lot: FT001; EXP: 07/24
- Report date
- Sep 27, 2023
- Product type
- Drugs
- Recall number
- D-1153-2023
- Classification
- Class II
- Recalling firm
- AMMAN PHARMACEUTICAL INDUSTRIES
- Product quantity
- 8,810 units
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Product was distributed to two (2) direct accounts in RI and CO.
- Recall initiation date
- Sep 1, 2023
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2023