Why it was recalled
Sub-Potent Drug: Subpotent assay results during stability testing.
Product description
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
Lot numbers, UPCs & expiration codes
Lot: 25MAR032, Exp. 07/16/2025.
Where it was sold
Nationwide in the USA
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-0536-2025
- Classification
- Class III
- Status
- Completed
- Recall initiated
- Jul 9, 2025
- FDA report date
- Jul 30, 2025
- Quantity
- 2,890 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Imprimis NJOF, LLC
Original FDA data
Every field from FDA enforcement report D-0536-2025, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 97183
- Address
- 1705 Route 46 Ste 6B
- Code information
- Lot: 25MAR032, Exp. 07/16/2025.
- Postal code
- 07852-9720
- Report date
- Jul 30, 2025
- Product type
- Drugs
- Recall number
- D-0536-2025
- Classification
- Class III
- Recalling firm
- Imprimis NJOF, LLC
- Product quantity
- 2,890 vials
- Reason for recall
- Sub-Potent Drug: Subpotent assay results during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 9, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 21, 2025