Why it was recalled
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Product description
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
Lot numbers, UPCs & expiration codes
Lot#s: 22DEC065 (MDU), exp: 09/29/2023; 23JAN024 (MDU), exp: 10/13/2023; 23FEB024 (SDU), exp: 11/09/2023; 23MAR013 (SDU), exp: 12/01/2023; 23MAR033 (SDU), exp: 12/16/2023; 23MAY044 (SDU), exp: 03/23/2024;
Where it was sold
Product was distributed to physician's offices nationwide.
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-0043-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 20, 2023
- FDA report date
- Oct 25, 2023
- Quantity
- 6,228 bags + 15,360 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Imprimis NJOF, LLC
Original FDA data
Every field from FDA enforcement report D-0043-2024, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93093
- Address
- 1705 Route 46 Ste 6B
- Code information
- Lot#s: 22DEC065 (MDU), exp: 09/29/2023; 23JAN024 (MDU), exp: 10/13/2023; 23FEB024 (SDU), exp: 11/09/2023; 23MAR013 (SDU), exp: 12/01/2023; 23MAR033 (SDU), exp: 12/16/2023; 23MAY044 (SDU), exp: 03/23/2024;
- Postal code
- 07852-9720
- Report date
- Oct 25, 2023
- Product type
- Drugs
- Recall number
- D-0043-2024
- Classification
- Class III
- Recalling firm
- Imprimis NJOF, LLC
- Product quantity
- 6,228 bags + 15,360 boxes
- Termination date
- Jul 17, 2025
- Reason for recall
- Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
- Distribution pattern
- Product was distributed to physician's offices nationwide.
- Recall initiation date
- Sep 20, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 13, 2023