Why it was recalled
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Product description
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.
Lot numbers, UPCs & expiration codes
Lot 24OCT041, Exp 04/26/2025
Where it was sold
FL and NY
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-0305-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Feb 24, 2025
- FDA report date
- Apr 9, 2025
- Quantity
- 2822 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Imprimis NJOF, LLC
Original FDA data
Every field from FDA enforcement report D-0305-2025, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96329
- Address
- 1705 Route 46 Ste 6B
- Code information
- Lot 24OCT041, Exp 04/26/2025
- Postal code
- 07852-9720
- Report date
- Apr 9, 2025
- Product type
- Drugs
- Recall number
- D-0305-2025
- Classification
- Class III
- Recalling firm
- Imprimis NJOF, LLC
- Product quantity
- 2822 bottles
- Reason for recall
- Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.
- Distribution pattern
- FL and NY
- Recall initiation date
- Feb 24, 2025
- Center classification date
- Mar 28, 2025